cyrilzakka/clinical-trials huggingface dataset:
Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein.

Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage III-IVB)
* Karnofsky performance status ≥ or = to 70%
* Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl, platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl
* Adequate hepatic function:

Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used

* Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
* Women of childbearing potential must have a negative pregnancy test
* Patients must have ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll
* Prior radiation therapy for head and neck cancer
* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
* Inability to comply with study and/or follow-up procedures
* Women who are pregnant or lactating
* Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina, auto-immune connective tissue disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* History of severe infusion reaction to a monoclonal antibody
* Patients with nasopharyngeal carcinoma are not eligible
Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).


Eligibility Criteria:
Inclusion Criteria:

* Children 5-10 years
* IQ \> 50
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.


Eligibility Criteria:
Inclusion criteria:

1. Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
2. Insufficient glycaemic control (i.e. an HbA1c \> 6.5% and \<= 10.5%) despite treatment with diet and exercise and/or metformin (\>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be \<= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
3. Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
4. C-peptide levels (serum) \>= 1.5 ng/ml (at 90 min following a Boost challenge)

Exclusion criteria:

1. History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
2. Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
3. Treatment with weight reduction medications (including anti-obesity treatments)
Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
* Stable medical condition
* Age: between 18 and 65 years (inclusively)

Exclusion Criteria:

* Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
* Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
* Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
* Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
* Any other planned cosmetic procedure in the upper third part of the face during the trial period
* Inability to substantially lessen glabellar frown lines even by physically spreading them apart
* Marked facial asymmetry or ptosis of eyelid and/or eyebrow
* History of facial nerve palsy
* Any infection in the area of the injection sites
Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children. Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant recipients. Furthermore, protection due to naturally acquired immunity to VZV or post-immunization isn't well described in this population.The questions asked are:

* What is the influence of the immunosuppression required after orthotopic liver transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type varicella infection before OLT transplantation?
* What is the influence of the immunosuppression required after OLT on VZV-specific immunity elicited by varicella immunization before OLT transplantation?
* What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the induction of VZV-specific B and T cell responses elicited by VZV vaccination after OLT transplantation?
* What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the persistence / waning of B and T cell responses elicited by VZV vaccination?

VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Children either awaiting or recipients of a liver transplantation followed at the Children's Hospital of Geneva, Switzerland
* If vaccination offered: \> 12 months of age

Exclusion Criteria:

* Known wild type varicella exposure within four weeks of the initial vaccine
* Immunoglobulins administered within the 5 months preceding the receipt of varicella vaccine.
* Antiviral agents administered during the preceding 4 weeks
* Febrile illness (\>38.5°) in the 72 hours before vaccine administration
* Chronic aspirin therapy
* Any other live vaccinations within four weeks of receipt of varicella vaccine
* Female patients in childbearing age will have a pregnancy test at enrollment, and at the time of the second vaccine.
Early Detection and Intervention for Women At-risk of Psychosis

This study aims to examine the effectiveness of the cognitive behavioral therapy in preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.

Eligible subjects with informed consent provided will be randomly assigned to the cognitive behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session spanning for 8 week.

Eligibility Criteria:
Inclusion Criteria:

* women of age 18-64
* at-risk mental state as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS)
* with an informed consent
* able to understand Cantonese and read/write Chinese

Exclusion Criteria:

* those mental conditions that requires other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
* those medical conditions that severely limits participation, comprehension, or adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness);
* those who are receiving structured psychotherapy or counselling
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a reduction mammoplasty OR
* Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy
* Age \> 18
* Clinically detectable disease either by physical examination or radiographic studies
* Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients considered in "vulnerable" populations.
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed a previous study of baricitinib for the treatment of JIA.

Exclusion Criteria:

* Participants must not have had a permanent discontinuation of baricitinib in the prior study.
* Participants must have not developed an allergy to baricitinib.
Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI

Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology, especially with the limited and conflicted currently available data. Thus, we are conducting this prospective, non-randomised, open-label, clinical trial to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology during IVF/ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF/ICSI.
* Age: 18-39 years.
* Both ovaries present.

Exclusion Criteria:

* Age ≥ 40 years
* History of three or more previous IVF failures.
* Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
* Patients with Polycystic Ovarian Syndrome.
* Patients who previously undergo Unilateral Oophorectomy.
* Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.
* Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases,
* Cancer.
Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.

Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.

It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.


Eligibility Criteria:
Inclusion Criteria:

* Patients with grade IV glial tumor (glioblastoma according to WHO criteria) for which an indication of surgical excision with radiochemotherapy was chosen at a specialized multidisciplinary meeting of neuro-oncology at the CHU Amiens-Picardy.
* Patients should:

  * be able to be followed at the CHU of Amiens throughout their treatment,
  * be at least 18 years of age,
  * be informed (or trusted) of the conditions and objectives of the study,
  * having given their free and informed consent in writing,
  * have a life expectancy of more than 6 months,
  * be affiliated to a social security scheme.

Exclusion Criteria:

* Patients with recurrent tumors.
* Patients supported for another histology.
* Medical, psychological or social conditions that do not allow for proper understanding of the procedures inherent in the study.
* Patients under tutelage, curatorship.
Root Coverage Comparing Suturing Techniques

The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.

Thirty patients will be selected by meeting the following criteria:

Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be between ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable cemento-enamel junction. F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.

L. Patients who fail to complete the informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
* The mucogingival defect must be on a non-molar tooth.
* Patients must be between ≥ 18 years of age.

Exclusion Criteria:

* Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
* Patients requiring antibiotic prophylaxis.
* Root surface restorations at the site of recession.
* No detectable cemento-enamel junction.
* Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
* Patients who are pregnant or lactating.
* Patients who use tobacco products (smoking or smokeless tobacco).
* Patients with alcohol abuse problems.
* Patients undergoing long-term steroid therapy.
* History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.
* Patients who fail to complete the informed consent form.
Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury

Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents endothelial function, but no study has investigated whether acupuncture protects against ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.

This is a prospective crossover study clinical trial. In the first crossover study, 20 healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture or control. Endothelium-dependent, FMD of the brachial artery will be measured before and after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15 minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2 inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR injury are same as above mentioned.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer age 25 to 40 years
* non-smoker

Exclusion Criteria:

* hypertension (\>140/90 mmHg), diabetes any cardiovascular disease kidney disease thyroid disease cerebrovascular disease liver disease (bilirubin level \>2 mg/dl) pregnancy body mass index \>25 kg/m2
Heart Failure Decompensation And In-Hospital Mortality

Background and objectives Heart failure is a leading cause of morbidity and mortality worldwide and it is a major cause of emergency department access for cardiovascular disease patients. Aim of this study is to identify the markers, based on short-term temporal repolarization dispersion, capable to individuate decompensated chronic heart failure (CHF) patients at high mortality risk.

Method: We will obtain the following variables from ECG monitor, via mobile phone, during 5-minute recordings in decompensated CHF patients: RR, QT end (QTe), QT peak (QTp) and T peak to T end (Te) and we calculated mean, standard deviation (SD) and normalized index (N).


Eligibility Criteria:
Inclusion Criteria:

* at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF

Exclusion Criteria:

* pneumonia
* pulmonary embolism