cyrilzakka/clinical-trials huggingface dataset:
Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization

This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.

This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).

All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants of the already finished phase 2 clinical trial;
* Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
* Provide written informed consent.

Exclusion Criteria:

* None.
Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery

Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery.

Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care.

Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.


Eligibility Criteria:
Inclusion Criteria:

* Speaking the national language,
* The presence of primary breast cancer,
* The utilization of a smartphone for a minimum of one year,
* An age of 20 years

Exclusion Criteria:

* An uncontrollable medical problem,
* Having speech problems,
* Having hearing problems,
* Vision impairment,
* A psychiatric diagnosis/ongoing treatment
* Previous treatment due to a different type of cancer
* Rheumatological diseases,
* Fractures,
* Health problems leading to joint limitation,
* Amputation
Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease

The purpose of this study was to examine the impacts of a 12-week aquatic walking exercise program on body composition, vascular function, cardiorespiratory capacity, exercise tolerance, muscular strength, and physical function in patients with peripheral artery disease (PAD). The effects of the 12-week aquatic walking exercise program were also compared to the effects of a 12-week land-based walking exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral artery disease (ankle-brachial index between 0.6 and 0.9)
* 50-85 years of age
* Sedentary (less than 1 hour of regular exercise participation per week within the previous year)

Exclusion Criteria:

* current smoker (smoking within previous 6 months)
* psychiatric conditions
* pulmonary disease
* renal disease
* thyroid disease
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng/Ml (arm A) with standard of care (arm B).

The ADAPT ALEC trial is a phase IV, RCT in patients with ALK positive NSCLC treated with alectinib. A longer median progression free survival (mPFS) is expected in patients treated with standard dose alectinib when minimum plasma concentrations (Cmin) of alectinib exceed 435 ng/mL. The ADAPT ALEC trial will investigate whether using therapeutic drug monitoring (TDM) and increasing the dose of alectinib in patients with Cmin \<435 ng/mL, will raise the mPFS. We will compare mPFS in the subgroup of patients with an alectinib Cmin \<435 ng/mL using TDM and dose increases (arm A) to fixed dosing/standard of care (arm B).

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th)
* ECOG performance status 0-4
* Histologically or cytology confirmed NSCLC
* Documented ALK rearrangement based on an EMA approved test
* Patients can either be chemotherapy-naïve or have received one line of platinum-based chemotherapy
* Patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. Patients who do not meet these criteria are not eligible for the study
* Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment
* Signed writte Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures
* Observational other studies are allwoed for patients included in this study
* Local radiotherapy is allowed for pain

Exclusion Criteria:

* Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug
* Consumption of agents which modulate CYP3A4 or agents with potential QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)
* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the subject in this study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow--Mid-and-short Term Retrospective Study of 50 Cases

This study retrospectively analysed surgical outcomes of consecutive 50 cases to investigate the technical standard and clinical effect of extracapsular arthroscopic treatment for refractory tennis elbow.

To investigate the technical standard of extracapsular arthroscopic treatment for refractory tennis elbow. Consecutive 50 cases of refractory tennis elbow from 50 patients who underwent extracapsular arthroscopic surgery which performed independently by the same doctor from March 2012 to November 2016 was retrospectively analyzed. The key points of technical standard were summarized, including debridement, decortication and microfracture, suture under arthroscopy and postoperative cast fixation. Visual Analogue Scale(VAS), Mayo elbow performance score and Disability of Arm, Shoulder, and Hand outcome measure (DASH) were evaluated for postoperative results. The effects of various technical points were analyzed by rank sum test, independent sample t test, χ2 test and multiple logistic regression.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis was refractory tennis elbow;
2. Standard extracapsular method was used for surgery.

Exclusion Criteria:

1. Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months;
2. Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;
3. Case was complicated with other serious elbow joint diseases or injuries;
4. Patient did not sign the informed consent form.
Eyelid Androgen Treatment in Dry Eye

The purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. Several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.

The purpose of this study is to examine the safety and efficacy of transdermal eyelid application of testosterone gel along with the length of any beneficial effect following cessation of treatment.

Moderate to severe dry eye subjects will be enrolled into a randomized controlled trial with assignment to either an \~ 4.5% FDA-approved androgen gel (Natesto®, Acerus Pharmaceuticals, Mississagua, Canada) or a placebo formulated similar to Natesto® without testosterone. The gel will be applied to both eyelids in the morning and 12 hours later on both eyelids for a 30 day treatment period

Subjects will fulfil DEWS II criteria for eligibility and further be classified as moderate or severe based on DEWS II recommendations. A standardized examination involving signs and symptoms of dry eye and monitoring function of the meibomian and lacrimal glands, as well as clinical tear and ocular surface measures, IOP, and serum testosterone levels, at baseline, following 30 days of testosterone application, and at one and two months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe dry eye (TBUT \< 6.0 seconds, corneal staining \> grade 1.5, evidence of meibomian gland secretion compromise or Schirmer \< 5 mm wetting in 5 minutes)
* Age over 18
* Mild ectropion
* Previous contact lens wearers IF no wear for prior 6 months
* Punctal plugs if more than three months since placement
* Systemic tetracyclines, antihistamines if consistent dosing
* Sjogren's syndrome and related autoimmune conditions can be enrolled
* Patients using topical dry eye treatments (e.g., Restasis) if willing to discontinue for 30 days

Exclusion Criteria:

* If artificial tears or autologous serum used on day of study
* Ocular surgery if less than 12 months
* Punctal plugs if within 3 months of plug insertion
* Contact Lens wear within the six months prior to study
* PSA levels greater than 4 ng/ml or BPH
* Recent or current thrombolism
* Recent or current cardiovascular events (e.g., MI, stroke)
* Recent or current liver disorders
* Concurrent use of topical medications; e,g., topical glaucoma medications
* Diabetics
* Females of child-bearing age if not on reliable birth control
* History of breast cancer
* Cannot be taking insulin, warfarin or systemic corticosteroids
Palliative Care for Elderly Outpatients

Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. The study team will use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately make meaning of their life threatening illness.

The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per step), stepped-wedge design to compare effects of usual outpatient palliative care (usual care) and usual care along with either nurse-led or chaplain-led DT on patient outcomes, cancer prognosis awareness. The study team will assign 6 outpatient palliative care sites to usual care during the first-step, and randomly assign two sites per step to begin and continue DT led by either a nurse or a chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete pretest measures and satisfaction with palliative spiritual care services, receive usual palliative care, and complete posttest measures. During the experimental steps as part of routine palliative care service delivery, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level analysis with site, provider (nurse, chaplain) and time (step) included in the model, the study team will compare the usual care and each of the DT groups for effects on dignity impact, existential tasks, and cancer prognosis awareness and explore the moderating effects of physical symptoms and spiritual distress. The study team will also determine the effect of usual care and DT on the patient's satisfaction with palliative spiritual care services and the report of the patient's unmet spiritual needs.

Eligibility Criteria:
Inclusion Criteria:

1. cancer diagnosis (receiving cancer therapy or cancer control care)
2. receiving outpatient palliative care
3. age 55 years or older
4. able to speak and read English
5. physically able to complete the study (Palliative Performance Scale \[PPS\]\>50, suggesting a mean in life expectancy of 53 days at the time of enrollment since each patient is expected to participate in the study for 28-42 days maximum \[4-6 weeks\]).

Exclusion Criteria:

1. legally blind
2. cognitively unable to complete study measures (Mini Mental Status Exam \[MMSE\] does not correctly spell the word world backwards)
3. history of psychosis (medical record review)
4. Patient Dignity Inventory score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 \& 50% with high distress ≥ 3 problems rated \>2)
5. Spiritual distress score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 \& 50% with high distress ≥ 3 problems rated \>2)
6. are participating in another psychosocial intervention study that is focused on concepts similar to the proposed study.
Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.

Administration of siltuximab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* AML with a poor prognosis defined according to the criteria below:

LAM First line: Age \<60 years and unfavorable risk according to the 2017 ELN Age\> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age

* ECOG \<= 2
* Patient eligible for intensive chemotherapy
* Informed consent
* Liver function tests: transaminases \<3x normal, bilirubin \<1.5X normal
* Creatinine clearance\> 60ml / min
* LVEF\> = 50%

Exclusion Criteria:

* Patients with FLT3 ITD or TKD mutation eligible for FLT3 inhibitor therapy
* Uncontrolled infection
* Hep B, C, HIV +
* History of diverticulosis / diverticulitis
* Patients at high risk of gastrointestinal perforation
* No social security or any other scheme
* Pregnant women or patient unable to take contraception (pill, abstinence, IUD not allowed) in case of fertility. contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last SILTUXIMAB injection is not eligible for inclusion.
* Lactating women
* Minors
* Adults under guardianship, curatorship or legal protection
* Hypersensitivity to one of the active substances or to one of the excipients
Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women

Undernutrition has a known and well recognized negative impact on reproductive hormones, and ultimately fertility. In contrast, much less is known regarding the potential effects of overnutrition on the same hormones. Epidemiological data suggest that overnutrition might have a deleterious impact as well on the fertile potential of affected women, but very little is known about the mechanisms implicated. Such knowledge may be of importance, given the increasing prevalence of overweight and obesity worldwide.

In the present study, the investigators will perform a very detailed study of the minute to minute regulation of hormones of the neuroendocrine reproductive axis in normal young female volunteers. These studies will initially be performed at base line during isocaloric diet, where the stimulation of LH secretion by exogenous insulin will be tested during hyperinsulinemic eugylcemic clamp studies.

The same studies will then be repeated after a period of one month of controlled hypercaloric diet, where volunteers will receive an excess of approximately 30% KCal compared to their calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine reproductive hormones will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.

-

Exclusion Criteria:

* Personal history of endocrine dysfunction (any kind)
* Hormonal contraception
* Pregnancy
* Food allergy (any kind)
* Intense physical activity (\>4 hrs/week)
* Smoking
Tolerance Study of the Silicone Bands on Medical Compression Stockings

The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.

To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
* Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
* Subjects for whom the incriminated stockings provide class 2 compression or higher.
* Subjects covered by French national health insurance.
* Subjects who give their written informed consent and who accept the constraints of the study.

Exclusion Criteria:

* Known allergy to local anesthetics (lidocaine, etc.).
* History of anaphylactic shock.
* Ongoing antihistamine treatment or having taken during the week before inclusion.
* Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
* Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
* Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
* Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
* List of diseases which will prevent a subject from participating in the study:
* acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
* Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).
* Patients with an ongoing or previous history of mental or psychiatric disorder or condition or any other factor interfering with the ability to give informed consent.
* Any major systemic disease making the conduct of the study or the interpretation of the results difficult.
* Patients with ongoing or previous history of decompensated heart failure.
* Chemotherapy or active cancer.
* Pregnancy.
* Patients participating in an ongoing clinical trial or in the exclusion period of a previous trial.
* Persons deprived of their liberty by judicial or administrative decision or persons hospitalized without their consent.
* Legally protected adults under guardianship.
* If the patient accepts the biopsy proposed in the study:
* Patient for whom a skin biopsy is contra-indicated or requiring antibiotic prophylaxis,
* Anticoagulant taken during the 24 hours before inclusion.
* Subject with history of allergy to natural or synthetic latex, chlorhexidine, known healing disorder and/or viral diseases transmissible through the blood documented by the preliminary clinical exam.
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.


Eligibility Criteria:
Inclusion Criteria

ALS group:

* Subject is a male or female, aged at least 18 years.
* Subject is affected with ALS (familial or sporadic).
* Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
* Subject is willing and able to comply with all study procedures.
* Subject agrees to provide signed and dated informed consent form.

Control group:

* Subject is a male or female, aged at least 18 years.
* Subject is not affected with ALS or an ALS-related disorder.
* Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
* Subject is willing and able to comply with all study procedures.
* Subject agrees to provide signed and dated informed consent form.

Exclusion Criterion

• Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).