cyrilzakka/clinical-trials huggingface dataset:
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment \[complete remission (CR) rate 79% versus 31%, P \< 0.0005, respectively\]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction \[88% vs. 62.5%, P=0.05, for the presence of at least one of them\].

One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression.

In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.

Aim of the study:

To evaluate the association between response to chemotherapy, the degree of myelosuppression and the pharmacokinetics of doxorubicin in non-Hodgkin's lymphoma (NHL) patients.

Methods:

Study protocol:

1. At diagnosis

   Demographic and clinical parameters be collected (Appendix 1)
2. At course 2:

1. Doxorubicin will be given by 5-7 minutes infusion before the other medications (Doxorubicin doses will be collected (Appendix 1))

2. Blood will be sampled in course 2, at:

0 minutes 30 minutes 120 minutes 24 hours

Two 2ml EDT tubes will be drawn at each time The tubes will be centrifuged at 3000 RPM for 15 min. Plasma samples will be stored in - 700C

3. At the end of chemotherapy courses the following data will be collected (Appendix 2):

1. Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose reductions Neutropenic fever
2. Remission status

\[Complete remission (CR) - disappearance of clinical signs and symptoms of NHL along with normal laboratory and radiological findings\].

4. At the end of one year of CR

Remission status

Number of patients: 30

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biopsy proven intermediate grade NHL
* No previous chemotherapy
* At least 4 courses of R-CHOP at maximal doses are planned
* An informed consent

Exclusion Criteria:

* Do not meet all inclusion criteria
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.

Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.

Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.

Eligibility Criteria:
Inclusion Criteria:

* Gastroparesis (GCSI \> 2 OR Gastric emptying half-time \> 180 min OR gastric retention at 120 min \> 60% OR good response to botulinum if former criteria not met)

Exclusion Criteria:

* Age \< 18 years
* Inability to understand protocol
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age

To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.

Primary objective:

* To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
* To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.

Secondary objective:

•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Health infants aged 2 to 5 months.
* Legal guardian has signed written informed consent.
* Guardian may finish the whole visit in the judgment of investigator.
* 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
* Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.

Exclusion Criteria:

* Fever, body temperature ≥37.1℃.
* History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
* Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
* Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
* Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
* Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
* Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
* Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Myopia Control: a Comparison Study Between Atropine and MiSight

This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Children age of 5-12 years old at their baseline exam
* Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
* Gestational age ≥ 32 weeks.
* Birth weight \>1500g.

Exclusion Criteria:

* Current or previous form of myopia control
* Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
* Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
* Abnormality of cornea, lens, central retina, iris, or ciliary body
* Current or prior history of manifest strabismus, amblyopia, or nystagmus
* Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
* Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
* Abnormality of the cornea, lens, central retina, iris, or ciliary body.
* Prior eyelid, strabismus, intraocular, or refractive surgery.
* Down syndrome or cerebral palsy.
* Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
* Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
* Any condition that in the judgement of the investigator could potentially influence refractive development.
* Existing conditions that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, diabetes mellitus, pre-diabetes)
* Inability to comprehend and/or perform any study-related clinical tests
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after administration of the first dose of vaccine. For immunogenicity and safety evaluations, subjects who have already received Fluarix™ during the preceeding year will receive a dose of commercial vaccine and will form the control group of this trial.


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or Fluarix during a clinical study organized during the preceeding year

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
* History of confirmed influenza infection since a year from the date of previous vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Fractional Laser as Treatment Option for Various Pigment Disorders

The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.

Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.

Eligibility Criteria:
Inclusion Criteria:

* Becker nevus
* Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
* Age at least 18 years
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* use of bleaching creams during the past six weeks
* history of keloid
* active eczema
* suspected hypersensitivity to lidocaine or triple therapy
* use of isotretinoin in the past six months
* high exposure of the lesion to sunlight or UV light (UVA or UVB).
Cost of Illness Associated With Influenza in the UK

The objective of this study is to describe the burden associated with influenza in the UK, from both primary and secondary care perspectives, and to stratify the burden by the annual degree of mismatch between predicted and actual virus strains.

This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.
* Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.

Exclusion Criteria:

Not Applicable
Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Context Pain control is one of the most challenging problems encountered in postoperative period in bariatric patients. Currently there are no published studies evaluating Osteopathic Manipulative Treatment in bariatric surgery patients.

Objective The primary objective of this study is to determine whether Osteopathic Manipulative Treatment (OMT) can decrease pain score in bariatric patients. The secondary objective is whether OMT can improve patient satisfaction with overall treatment.

Design: A prospective randomized group controlled study.

Setting: A 293-bed non-for-profit teaching community hospital.

Methods Thirty-six patients scheduled for bariatric surgery as per ASMBS criteria were eligible for study from January 2017 through August 2018 at Flushing Hospital Medical Center, New York. Twelve patients were excluded.

Twenty-four patients were included into study and randomized to receive OMT(n=12) vs Control (n=12) intervention.

In Control group, patients received standard pain control protocol with morphine patient controlled analgesia pump (PCA) In OMT group, patients received standard postoperative pain protocol and OMT on postoperative day one. Three techniques were used (Sub-occipital Release, Thoracic Outlet Release, and Rib Raising). All patients received survey to complete prior to discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good, excellent) and data was analyzed.


Eligibility Criteria:
Inclusion criteria:

* Adults age 18 and older eligible for bariatric surgery as per American Society for Metabolic and Bariatric Surgery guidelines:
* BMI of at least 40, or greater than 100 pounds overweight.
* BMI of 35 or above and at least one or more obesity-related comorbidity such as type II diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease, or osteoarthritis.
* Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts.

Exclusion criteria:

* Age less than 18.
* Pregnant patients.
* Patients with history of chronic pain.
* Patients with diagnosed psychiatric disorders.
* Patients actively taking pain medication before surgery.
* Patients with prior surgical history
Neo-angiogenesis in Inguinal Henia Implant ProFlor

The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, a 3D dynamic responsive implant for inguinal hernia repair

Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor
* Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor
* Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor

Exclusion Criteria:

* immunosoppressive therapy, \> ASA 4 classification
Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.

Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities. Many cardiac problems were previously reported including left ventricular hypertrophy, right and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in normal left ventricular systolic function and can lead to diastolic heart failure postoperatively.

Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this problem may be underestimated. Transesophageal echocardiogram provides better cardiac view, but requires sedation during procedure. So, it is not practical for out-patient setting. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Every patient scheduled for bariatric surgery in Siriraj hospital

Exclusion Criteria:

* Patient refusal
* patient with contraindication for transesophageal echocardiogram such as preexisting esophageal disease, recent upper gastrointestinal bleeding, coagulopathy, etc. (according to American society of Echocardiography guideline)
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy postmenopausal women.
* Intact uterus.
* Clinical diagnosis of moderate to severe atrophic vaginitis.
PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up

The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.

Traditionally the material of choice for dental implants has been titanium. The success of such material has been unquestionable for the last decades. However a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. Esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. For this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants.

Since 2006 CeraRoot ceramic implants have been available in the market.

The reason for designing this PMCF is to evaluate the long term success of CeraRoot ceramic implants

To achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. It is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have received the studied ceramic implant after 27 August 2020.
* Patients of CeraRoot Clinic (Barcelona)
* Age \>18
* Single or multiple missing or hopeless teeth

Exclusion Criteria:

* Smokers.
* The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
* Untreated periodontal conditions
A French Multi-centric Atrial Fibrillation Catheter Ablation Survey

Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients.

We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter

Exclusion Criteria:

* patients undergoing catheter ablation of other types of arrhythmia
Misoprostol for Second Trimester Termination of Pregnancy

The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy


Eligibility Criteria:
Inclusion Criteria:

* gestational age between 12-24 weeks
* live fetus
* singleton pregnancy
* Bishop score \<5
* no uterine contraction

Exclusion Criteria:

* prostaglandin allergy
* a scar in uterus
* uterine abnormality
* premature rupture of membranes