cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
* Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of \>50 kg
* HbA1c value at the screening visit meeting once of the following criteria:

  * Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
  * Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
* Fasting plasma glucose concentrations\<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
* Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Exclusion Criteria:

* History of Type 1 diabetes mellitus or secondary forms of diabetes
* One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.
* History or evidence of diabetic complications with significant end organ damage, such as

  * Proliferative retinopathy and/or macular edema;
  * Diabetic neuropathy complicated by neuropathic ulcers;
* Screening seated systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
* Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless

Homelessness, also name the fourth world, is a growing public health problem worldwide. Previous studies showed that up to 30% of the homeless people reported pruritus that often results in itchy lesions, which expose them to bacterial skin infections.

The investigators therefore conducted a randomized, double-blind, placebo-controlled trial to test the hypothesis that a single oral dose of ivermectin was effective in significantly reducing the prevalence of pruritus in a sheltered homeless population.


Eligibility Criteria:
Inclusion Criteria:

* Patient HOMELESS PERSON " individual who has no regular access to a conventional residence ", appearing during the period of study at reception centers (Forbin or Madrague Ville) and being in the habit of wearing there (at least 4 times a week),
* Male genital organ and feminine,
* Of more than 18 years old,
* Presenting of the prurit, hurts of scratching or the louses
* Wishing to change his underwear,
* Having given his lit(enlightened) consent

Exclusion Criteria:

* Woman presenting a sexually transmitted infection (infection with gonococcus, with Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results of which will be known only secondarily.
* Pregnant Woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy.
* Woman removing her consent during the study.
* Lost sight Woman.
* Woman deprived of freedom, judicial or administrative;
* Woman hospitalized for quite other reason that looks for her(it);
* Woman hospitalized in a sanitary establishment or social in the other purposes that the research;
* Major Woman except state to express its consent
The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used.

The research hypothesis is that very few major complications are expected showing the safety of direct introduction.

A look back at the practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)


Eligibility Criteria:
Inclusion criteria:

* Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022.
* Subject, having not expressed their opposition to the reuse of data of their data for the purposes of scientific research.

Exclusion criteria:

- Subject having expressed its opposition to the reuse of its data for scientific res
Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients

The purpose of the study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.

Estrogen plays a critical role in breast cancer growth in pre-and post-menopausal women. The aromatic catalyzer has relationship with biosynthesis of estrogen, therefore, aromatic inhibitors became as a standard therapy of breast cancer in post-menopausal women. Arthralgia and joint stiffness are most common side effect in aromatic inhibitor treatment. Yoga is benefit for the patients with chronic pain improvement, and also can improve quality of life. Therefore, the purpose of the present study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks). There is two weeks wash out period after finishing 6 weeks treatment, and then the patients in control group changed to treatment, in contrast, the patients in the treatment changed to control group. The assessment time was pre-treatment (vision 1), finishing 6 weeks treatment (vision), finishing 6 weeks treatment after crossover (vision 3). The major assessment was brief pain inventory scores changed The results in the present study predict Yoga treatment for 6 weeks can improve aromatic inhibitor-induced knee pain and also can improve quality of life in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with breast cancer and is taking an aromatic ring enzyme inhibitor. Knee joint pain for more than three months. Ages are over 20 years old and under 70 years old.

Exclusion Criteria:

At the same time, there are multiple sources of pain associated with non-breast cancer, such as visceral pain, traumatic pain, which must be excluded by the moderator.

Addicted drug abusers, subject to the judgment of the host. Women who may be pregnant, pregnant women, within three months after childbirth.

Have a serious mental illness or an unstable mental state, which will affect the clinical assessment.

Severe hearing impairment, visual impairment, or dementia. It is not easy to measure by the host.

Limb edema and severe skin damage are not suitable for yoga practitioners by the physician.

The spinal lesions are excessively severe, affecting the normal function of the operation, and the test cannot be completed.

Have been a yoga practitioner for nearly a month, or a regular exerciser for over 90 minutes per week for the past month.

Cancer has been transferred (stage IV)
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.

Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity


Eligibility Criteria:
Inclusion Criteria:

* presence of \> 25% of blast in bone marrow
* treatment with second line therapies
* patients with resistant disease i.e. with \>25% of blasts 21 days after the last cytostatic agent administration
* children with persistent high MRD level (\> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
* Relapsed after \> months after SCT
* Karnofsky score \>50
* a Forced Espiratory Volume \>30%
* sufficient hepatic and renal function defined as creatinine levels \<2 × ULN, bilirubin \<1.5 × ULN
* aspartate and alanine aminotransferases \<10 × ULN.

Exclusion Criteria:

* isolated extra-medullary relapse, and active infections
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.

This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.

Eligibility Criteria:
Inclusion Criteria:

* bilateral diabetic macular edema
* center involving confirmed by Optical coherence tomogram (OCT)

Exclusion Criteria:

* any non-diabetic macular edema
* significant media opacities
* previous laser treatment, any intraocular surgery within the past 6 months
* previous intravitreal injections of any drug within the past 6 months
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion

High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.


Eligibility Criteria:
Inclusion criteria:

* Presenting for surgical abortion
* Gestational age \<12 weeks
* \< 18 years of age
* Agrees to be randomized

Exclusion criteria:

* Allergy to study medications (lidocaine, fentanyl, midazolam)
* \> 18 years of age
* Fetal demise
* Pre-procedure use of misoprostol
* No means of transportation following procedure
Evolution of the Relationship Between Central and Peripheral Arterial Wave Velocities as a Function of Age

Acquisition of synchronized cardiovascular signals from non-invasive measurements (ECG, photoplethysmography pulse sensors, inductance plethysmography) in healthy volunteers aged from 18 to 75, during spontaneous ventilation with apneas (20 seconds) for a total acquisition time of 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 75 years of age
* No acute cardiovascular pathologies less than 2 years old,
* No chronic cardiovascular pathologies.
* Stature compatible with the use of the plethysmography T-shirt.
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Signed informed consent form

Exclusion Criteria:

* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).
* Personnel with a hierarchical link to the principal investigator
* Subjects excluded from another study,
Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.

This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 1-16 upon enrollment
* Diagnosis of Cystic Fibrosis

Exclusion Criteria:

* None
Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects

The study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (BMI≥25 Kg/m2)

Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP), bioimpedance and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Sleep Apnea and Lung Cancer

cases of locally advanced non small cell lung cancer (diagnosed by PET/CT scan and histopathological confirmation) will be screened for sleep disorders by Epworth sleepiness scale then confirmed by full night polysomnographic study. Blood sample to detect some genetic determinants will be withdrawn


Eligibility Criteria:
Inclusion Criteria:

* patients with locally advanced non small cell lung cancer

Exclusion Criteria:

* unable or refuse to perform sleep study
* metastatic cases
School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays

This proposal aims to test whether a proposed community-clinical linkage (CCL), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. The investigators designed an educational-clinical linkage model, Preschool and Me (PreM) which incorporates key components of a CCL. It also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based services.

Participants (n=320) will be randomized to either: 1) 6 months of PreM (intervention group) or 2) a waitlist control arm receiving the intervention after a 6-month delay. All participants will be followed for 12 months with data collection occurring at 4 timepoints (baseline, 3-, 6- and 12-months). There will also be a simultaneously conducted mixed-methods implementation evaluation focusing on implementation outcomes to serve as indicators for implementation success; measures of implementation quality; and intermediate outcomes to understand and address successes and failures in relation to clinical outcomes.

Eligibility Criteria:
Parent-child dyads who meet inclusion criteria will be enrolled.

Child inclusion criteria are:

1. Meets age requirements for early childhood special education (ECSE) services for Illinois (i.e., 3-5 years old);
2. diagnosed with a developmental delay or disability (DD) or determined to be at risk for DD (clinical concerns raised by primary care provider/healthcare provider or by parents at the time of enrollment);
3. is not receiving any ECSE services.

Exclusion Criteria:

if inclusion criteria is met, no other exclusion criteria will be applied.

Parent inclusion criteria are:

1. aged18 years or older;
2. lives in Chicago;
3. speaks English or Spanish;
4. a legal guardian of a child who meets inclusion criteria.
Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).

Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related changes in the retina through biochemical and functional evaluations, but it is unclear whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the natural history and progression of age-related macular degeneration (AMD). AMD is a disease affecting the macula, the part of the eye containing cone photoreceptors at the center of the visual field. The macula is responsible for vision in most daily functions, including reading, seeing fine details, and colour recognition. Severe AMD can lead to a central scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD characterized by the development of drusen, a buildup of extracellular material . The investigators are focused on the group with the highest risk of developing the two advanced forms of AMD \[wet AMD or central geographic atrophy\]: patients with unilateral wet AMD and dry AMD in their other eye. The study will consist of following up a cohort of such subjects and monitoring their visual function in a comprehensive manner. Working in concert with clinical ophthalmologists and basic scientists, the investigators will monitor "DHA+EPA" and "Omega6:Omega3 fatty acid ratio" levels in the blood, inherited predispositions through genetic analysis, lipofuscin (an accumulated waste product) levels \& AMD progression via fundus photography, visual acuity, and retinal function via full-field and multifocal electroretinograms. These different factors will be cross-correlated and evaluated to determine how omega-3 fatty acids affect the progression of AMD.


Eligibility Criteria:
Inclusion Criteria:

* 50+ years of age
* NVAMD (Wet) in one eye, early or intermediate dry-AMD in the fellow eye
* taking AREDS vitamins (or equivalent)

Exclusion Criteria:

* Central geographic atrophy
* Diabetic retinopathy
* Ocular surgery in the eye with dry-AMD (not including cataract IOL surgery)
* Underlying ocular pathology in the eye with dry-AMD (especially glaucoma, dense cataracts, and retinitis pigmentosa)