cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Goldcrest Patch Performance

The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.

The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.

The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.

Eligibility Criteria:
Inclusion Criteria for all Subjects:

* Adult Females, 22 to 70 years of age.
* Must be able to read and speak English.
* Able and willing to provide written informed consent.

Inclusion criteria that apply to the pregnant person arm only:

- Pregnancy of greater than or equal to 32.0 weeks gestation per self-report.

Exclusion Criteria:

* Skin irregularities or other characteristic (such as scars, moles) on abdominal area that could interfere with completion of study procedures or identify a subject;
* Subjects who have implantable devices such as Transcutaneous Electrical Nerve Stimulation (TENS) machines, Cardiac Pacemakers or Cardiac Defibrillators
* Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study, such as silicone;
* Subjects over the age of 70;
* Unable to read or speak English language
* Direct employees or contractors of GE HealthCare, or any company that makes fetal monitoring devices.

Exclusion criteria that apply to specific arms only:

* Non-Pregnant Arm: Subjects who are currently pregnant, or unsure of pregnancy status per self-report;
* Pregnant Arm: Multiple gestation pregnancy or those self-reported to have been diagnosed as high risk by a provider (e.g., pre-eclampsia, gestational hypertension, being followed by a perinatologist).
Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness

Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.

Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).

Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian healthy female subjects,
* complaining vaginal dryness,
* women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place,
* women who agree not to start a replacement therapy during the whole duration of the study,
* women who do not present any active cutaneous pathology of external and internal genitalia,
* women who did not receive any drug or cosmetic treatment on their genitalia during the 2 months preceding the trial,
* women who did not apply vaginal products within at least 1 month before the inclusion in the study,
* women who accept to use only the products authorised by the protocol,
* women who accept not to undertake any treatment for internal and external genitalia during the trial,
* women who did not use, phytoestrogenes based products on treated areas less than 4 weeks before inclusion time,
* women accepting to sign the Informed consent form,
* women able to read the material dedicated to volunteers, to abide by the rules of the protocol and ready to accept its constraints

Exclusion Criteria:

* Volunteers not fulfilling inclusion criteria,
* severe symptoms of vaginal dryness, associated with mucosal signs
* history of intolerance to a vaginal product,
* concomitant participation to another trial,
* refusal to sign the Informed Consent form,
* known allergy to one or several ingredients of the product on trial,
* change in the normal habits in the last 3 months,
* participation in a similar study during the previous 3 months,
* whose insufficient adhesion to the study protocol is foreseeable
* women who start a replacement therapy during the trial
* women who experience during the study the occurrence of any foreseeable risk to use daily the product on trial.
Effects of School Gardens on Children's Diet, Nutritional Knowledge, Etc.

The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes.

Schools in New York, Washington State, Iowa, and Arkansas were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline data collection.

Eligibility Criteria:
Inclusion Criteria:

* Schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
* Schools did not already have a school garden.

Exclusion Criteria:

none.
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant at the age of 11 - 17 weeks.
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by clinical examination before entering into the study.
* Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria:

* Previous vaccination against measles, mumps, rubella and/or varicella.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* Major congenital defects.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

Maternal morbid obesity is an important risk factor in modern obstetrics, it has been associated with higher infertility rates and obstetrics complications. Bariatric surgery proven to achieve long term weight loss with improvement in all obesity related morbidities. This study was to compare the 5 years outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of fertility outcomes, breast feeding, weight loss, safety, and resolution of obesity related co-morbidity.

This study included 197 adult morbidly obese females, 111 underwent LSG (group I) and 86 LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary goal of conceiving and complaining from infertility either primary or secondary as well as those who were seeking weight loss in preparation for marriage

Exclusion Criteria:

-
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.

Primary objective

- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

Secondary objectives

* Improvement of respiratory performance.
* Improvement of acute phase inflammation indices.
* Evaluation of known adverse events related to the use of the drug.
* Evaluation of the epidemiological parameters in COVID-19 patients.
* Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives
* Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
* Imaging (CT / ECO / RX) positive for pneumonia;
* Oxygen saturation (SaO2) of 93% or less in the environment;
* Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
* Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
* Release of informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding;
* Patients already in assisted breathing with tracheal cannula;
* Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
* Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
* Patients with renal insufficiency;
* Patients with positive quantiferon;
* Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);
* Patients with neutropenia equal to or less than 1000 PMN / mmc;
* Patients with thrombocytopenia equal to or less than 100000 / mmc.
* HCV and / or HBV positive patients, HIV.
CareLink® Network Evaluation

The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.

Evaluation's objectives:

Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)

Eligibility Criteria:
Inclusion Criteria:

* Patients who have an implanted Medtronic ICD, CRT-D device that is supported by the Medtronic CareLink® Network
* Patients have to sign the Medtronic CareLink® "Statement of Privacy Principles" and the "Evaluation Data Protection Statement" documents

Exclusion Criteria:

* Patients with exclusion criteria required by local law
* Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)
Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

Present treatment of children with stable ankle and foot injuries very often involves a period in plaster cast(s). In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.

There are many benefits to this approach including progressive rehabilitation, reduced costs in materials and personnel, improved hygiene and adaptability of fit. The use of such a splint has not been investigated in children and this project aims to assess the value of introducing this as a treatment mode through the analysis of outcomes between traditional cast treatment and the newer removable brace/splint treatment. The outcomes will include patients' preferences, clinical results and relative costings.

The study is a longitudinal cohort study of all eligible ankle injuries per the eligibility criteria presenting to Sheffield Children's NHS Fountain Trust. These children and their parents/carers are presented with an information sheet regarding the study and are then invited to enter the study.

Once consented - by appropriately trained research and/or clinical staff - those recruited are treated in either cast or boot on the basis of block randomisation.

Patients are followed up per protocol and outcomes completed by patients and clinicians.

Study information is kept securely for future analysis and write up.

Eligibility Criteria:
Inclusion Criteria:

1. 6-16 years
2. foot size has to be large enough for the smallest available DJO Walker
3. presentation to the Sheffield Children's Hospital Emergency Department or Fracture Clinic (some patients present directly to the fracture clinic if they have been injured elsewhere (eg. on holiday or in competitions)
4. acute injuries (less than 72 hours old)
5. stable ankle injuries. This is all ankle sprains and all stable undisplaced ankle fractures. The key here is that the patient would be able to weightbear in cast/DJO Walker without detriment to the ankle injury, pain permitting
6. signed consent

Exclusion Criteria:

1. \<6 and \>16
2. foot size too small for DJO Walker
3. any unstable ankle injury
4. any ankle injury that could not be treated weightbearing in cast/aircast boot (pain permitting)
5. patients/carers unwilling to participate in the study
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool

Multicenter, observational, prospective, biological pilot study on liquid biopsy, aimed at investigating methylation profiles in relation to the early diagnosis of bladder cancer, to validate the potential of commercially available tests (e.g. BladderCARE, Bladder EpiCheck), to apply and validate tests based on targeted multi-marker or genome wide analyzes via NGS and to identify methylation profiles as a tool to infer clinical outcome.

The study has the primary objective to investigate the diagnostic capacity of methylation levels in urine samples, furthermore it has the secondary objective of applying an NGS test on the urine sample capable of evaluating the highest methylation levels comprehensive, with better analytical performance than the currently available standard on the market, leveraging targeted sequencing of multiple genes or global analysis of the whole methylome.

To describe the diagnostic performance of the methods in a real-world clinical environment and identify the characteristic methylation profiles capable of stratifying patients with different prognoses, and finally to explore the potential economic impact of applying such tests as tools alternatives to conventional practices.

Eligibility Criteria:
Inclusion Criteria:

Patient group

* age ≥ 18 years
* proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle)
* performance status (PS) 0-1
* ability to follow the procedures established by the study
* written consent for participation in the study and data processing

group of healthy subjects

* age ≥ 18 years
* ability to follow the procedures established by the study
* written consent for participation in the study and data processing

Exclusion Criteria:

Patient group

* presence of metastatic bladder cancer
* lack of autonomy in following the procedures established by the study

group of healthy subjects

* previous or current clinical history associated with bladder cancer
* diagnostic suspicion associated with tumor pathologies
* ongoing or previous systemic oncological treatments
* presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile
* existing pharmacological treatments (and/or any other type of treatment) that could alter the results of the analyzes conducted for the present study
* lack of autonomy in following the procedures established by the study
Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer

With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.

Surgery or complex medico-surgical procedures - that associate chemotherapy and/or radiotherapy and surgery, can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition, but low for physical exercise, due to heterogeneous programs with often bad adherence. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.

PROADAPT pilot study is a standardized geriatric intervention constructed on a multi-professional and multi-disciplinary basis after a systematic analysis of published data.

This intervention was designed to be implemented pragmatically in the centers according local habits in several distinct hospital contexts in different tumor contexts.

It consists in:

1. before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation;
2. during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery;
3. bridging and post-discharge interventions for hospital-to-home transition.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥70 year old OR patient ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6);
* Histologically or cytologically proven cancer.
* Life expectancy \> 3 months.
* Written informed consent obtained
* Covered by a Health System where applicable.

Exclusion Criteria:

* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Patient unable to be regularly followed for any reason (geographic, familial, social, psychologic).
* Any mental or physical handicap at risk of interfering with the appropriate treatment.
* Any administrative or legal supervision where applicable
Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.

Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.

Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged above 18 years
* With septic shock
* Scheduled for general anesthesia

Exclusion Criteria:

* Patients under 18 years
* Burn patients