cyrilzakka/clinical-trials huggingface dataset:
Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with advanced nonsmall-cell lung cancer
* known HER2 exon-20 insertion
* treated with chemotherapy and/or HER2-targeted drugs

Exclusion Criteria:

* none
Mental Practice in Chronic, Stroke Induced Hemiparesis

Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.


Eligibility Criteria:
Inclusion Criteria:

* a Fugl-Meyer score \> 27, which is indicative of minimal to moderate arm impairment;
* stroke experienced \> 6 months prior to study enrollment;
* minimal cognitive impairment, a score \> 25 on the Folstein Mini Mental Status Examination (MMSE);
* age \> 21 years old and \< 80 years old;
* have experienced one clinical stroke as verified by a physician;
* discharged from all forms of physical rehabilitation targeting the affected arm.

Exclusion Criteria:

* \< 21 years old;
* excessive pain in the affected hand, arm or shoulder, as measured by a score \> 5 on a 10-point visual analog scale;
* excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
* currently participating in any experimental rehabilitation or drug studies targeting UE;
* mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
* history of parietal stroke (because some data suggest that ability to estimate manual motor performance through mental imagery is disturbed after parietal lobe damage);
* affected arm joint restriction that in the opinion of the investigator would hinder study participation
Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven invasive pancreatic ductal carcinoma
* Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

  1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
  2. Patients indicated distal pancreatectomy with en bloc celiac axis resection
* PS (ECOG) 0-1
* ≧20 years old and \< 80 years old
* First line treatment
* The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
* Written informed consent to participate in this study

Exclusion Criteria:

* Severe drug hypersensitivity
* Multiple primary cancers within 5 years
* Severe infection
* With grade2 or more severe peripheral neuropathy
* With intestinal paralysys, ileus
* Interstitial pneumonia or pulmonary
* With uncontrollable pleural effusion or ascites
* Receiving atazanavir sulfate
* With uncontrollable diabetes
* With uncontrollable heart failure, angina, hypertension, arrhythmia
* With severe psychological symptoms
* With watery diarrhea
* Pregnant or lactating women, or women with known or suspected pregnancy
* Inappropriate patients for entry on this study in the judgment of the investigator
Acceptability and Tolerance Study of Peptide Feed with Fibre

Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.

Eligibility Criteria:
Inclusion Criteria:

* Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition

  * Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre.
  * Aged 18 years and above.
  * Willingly given, written, informed consent from patient

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator

  * Patients receiving mechanical ventilation, sedation or inotropic support
  * Patients on total parenteral nutrition
  * Known food allergies to any ingredients (see ingredients list) or galactosaemia
  * Patients with significant renal or hepatic impairment
  * Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
  * Participation in another interventional study within 2 weeks of this study.
  * Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
  * Patients with known or suspected ileus or mechanical bowel obstruction.
EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study

Overall Study Design and Plan Description

* The study will be conducted on women with fertility difficulties who are designated for intrauterine insemination treatment (IUI). The research sample size is 137 treatment cycles per group (total of 274 treatment cycles). The women will be randomly divided into two groups. Some will undergo the standard bolus IUI treatment and others will be treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive in the first treatment will next receive the alternative treatment. This means that a woman treated with the IUI method who does not become pregnant will then be treated with SRI, and vice versa (crossover method). The study will include women treated with Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will undergo at least 2 insemination cycles (unless pregnancy has already been achieved).
* Before beginning the hormone treatment, each couple will have the trial procedure explained to them. This explanation will include all the detailed information and instruction about the IUI and the Slow Release Insemination methods. A Patient Information Sheet will be available to them.
* Preparation of the spermatozoa for intra uterine insemination will be identical to the method performed currently before IUI.

Approximately two weeks after the insemination treatment, a blood sample will be taken from the woman to check for Beta hCG levels to indicate pregnancy.

Hypothesis:

SRI leads to higher pregnancy rates compared to standard IUI

Primary endpoint:

• Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the pregnancy rate of women designated for intra uterine insemination in comparison to the accepted IUI method.


Eligibility Criteria:
Inclusion Criteria:

1. Women with primary or secondary infertility after 6 months of unprotected intercourse who are candidates for IUI
2. Age of the woman - 20 to 40 years old
3. Normal uterus x-ray (HSG) or Chromotubation to determine tubal patency
4. Women with infertility on a background of non-ovulation
5. Infertility on a background of a male problem (over 10 million/ml motile sperm cells per sample)
6. Infertility on a background of unexplained cause
7. Same sex patient / single patient
8. Signed informed consent

Exclusion Criteria:

1. Woman under the age of 20 or over the age of 40 years
2. Female infertility on mechanical background affecting the uterus or Fallopian tubes
3. Infertility on male background of medium to very low level of spermatozoa - less than 10 million/ml motile sperm cells per sample
4. Men and women who are opposed to the random spermatozoa insemination method
5. Participants who are not willing to sign the Consent Form
6. BMI \>30
COVID-19 Immune Repertoire Sequencing

This concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).


Eligibility Criteria:
Inclusion Criteria:

* laboratory confirmed COVID-19 acute infection
* be older than 18 years of age
* be hospitalized at the UZA
* willing and able to provide written informed consent by the participant or its legal representative (for instance in case of medical incapacitation)

Exclusion Criteria:

* younger than 18 years old
* Ambulatory patients
Clinical Study to Evaluate Dental Plaque

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers at least 20 - 51 years of age
* Good general health
* Must sign informed consent form
* Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus)
* 5 or more decayed untreated dental sites at screening (cavities)
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affecting salivary function
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1
* Pregnant or nursing women
* Participation in any other clinical study within 1 week prior to enrollment into this study
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates
* Current use of Antibiotics for any purpose
* Presence of an orthodontic appliance which interferes with plaque scoring
* History of allergy to common toothpaste ingredients
* History of allergy to arginine (amino acid)
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children

The aim of this research is to study the effect of an animal-assisted activity (AAA) on the stress level of hospitalized children.

A hospitalization is a major stressor in a child's life, which can have negative effects on recovery. It is assumed that animal-assisted interventions can have a positive effect on the level of stress, but this has not yet been sufficiently researched. This study aims to measure a possible effect. Children who are hospitalized will receive an animal-assisted activity. A normal afternoon in their hospital room counts as a control activity. The stress level is measured through saliva cortisol, blood pressure, heart rhythm variability and a visual analogue stress scale.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized in the Universitair Ziekenhuis Brussel
* dutch and/or french speaking.

Exclusion Criteria:

* decreased immunity
* multi-resistant germs
* disturbed diabetes
* fever of unknown origin
* fear of animals
* dogs or cats allergy
* cognitive impairment
Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement

This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

The ACIST-FFR study is a prospective, open label, observational, multi-center study designed to assess the differences, if any, between FFR measured by the Navvus catheter and a commercially available 0.014-inch pressure guidewire (St. Jude Medical, Volcano, hereafter referred to as the PW) in subjects with coronary artery disease (CAD) undergoing coronary angiography. This will be accomplished by comparing the FFR measurement obtained with the ACIST Medical Systems RXi System and Navvus catheter with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time.

Eligibility Criteria:
General Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has a clinical indication for coronary angiography
* Subject or subject's legal representative has the ability to understand and provide signed consent for participating in the study

Angiographic Inclusion Criteria:

* Vessel has a TIMI flow = 3
* Subject has de novo lesion which physician has determined has a clinical indication for FFR measurement
* RVD of the target lesion is assessed by the operator to be ≥2.25 mm.

General Exclusion Criteria:

* Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography
* NYHA Class 4 severe heart failure

Angiographic Exclusion Criteria:

* Target vessel has angiographically visible or suspected thrombus.
* Target lesion is within a bypass graft.
* Angiographic evidence of a dissection prior to initiation of PW measurements.
* Target vessel contains excessive tortuosity or calcification.
Respiratory Health of Elite Athletes

Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups, many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games. A consultation of the coaches of these National Teams revealed that although a large proportion of these athletes present various cardio-respiratory symptoms, they do not have a rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the elite athlete's population of the Quebec area.

Cardiorespiratory problems are therefore commonly found in high-level athletes. However, these pathologies are not well characterized in athletes and the associated symptoms often not well perceived. These problems can be serious and it is important to detect them before they appear1 while setting up a systematic medical follow-up. Health professionals should monitor health of the young athletes and help to reduce the risks associated with high level exercise. The following project is an evaluation and follow-up program of high-level athletes, aiming at gathering key-information on long-term effects of high-level training on cardio-respiratory and metabolic parameters. Our aims will be

1. to establish a long-term program of systematic evaluation and follow-up of cardiorespiratory health and performance of high elite athletes.
2. to evaluate the prevalence of respiratory, circulatory and metabolic problems among high-level athletes
3. to evaluate the effects of treatments on cardiorespiratory conditions and exercise performance in athletes who need asthma medication.


Eligibility Criteria:
Inclusion Criteria:

* Athletes training more than 10 hours per week-

Exclusion Criteria:

* asthma or other pathologies that may interfere with the study
* Smokers
* Obese of with a BMI more than 29
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.

The study has the following objectives:

* Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.
* Evaluate patient experience and toxicities associated with TheraSphere treatment
* Evaluate predisposing factors that may influence results and toxicity

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

1. Range of patients who can be offered TheraSphere®
2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
3. Survival time
4. Determine response in relation to histology and other parameters
5. Ability to tolerate repeat treatments
6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18.
2. Cancer visible in liver on CT,MR,US or PET scan.
3. Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
4. Life expectancy greater than 2 months
5. Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
6. Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion Criteria:

1. Vascular shunt that cannot be corrected.
2. Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
3. Pregnancy
4. Hematologic primary such as lymphoma, leukemia, myeloma.
5. Body weight 300 lbs. and above
6. Evidence of portal hypertension, splenomegaly or ascites.
Bone Microcirculation After Remote Ischemic Preconditioning

In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
* Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
* Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone.
* Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

* below 18 years of age
* scar tissue above measuring focus
* osteoporosis or comparable bone disease
* medication that influences bones