cyrilzakka/clinical-trials huggingface dataset:
Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return

The primary goal of this study is to assess in vivo the efficacy of the insoles in improving venous return in subjects affected by this problem after 14 days of medical device use, by self-assessment, filling-in questions regarding Quality of Life, in comparison to the baseline.

The secondary goals of this study are (1) to assess in vivo the perception of subjects about the rapid relief felt after 7 days of using the same medical device, by self-assessment, filling-in three subjective evaluation questions, and (2) to assess in vivo the usability of the subjects regarding the same medical device after 14 days of its use, by self-assessment, filling-in subjective evaluation questions.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Female/Male;
* Age: with 18 years old and older;
* Having signed an Informed Consent Form (ICF);
* Willingness, ability and likeliness to comply with all the study procedures and restrictions;
* Ability to give informed consent;
* Available during the entire study period;
* Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents;
* Affected by a symptomatic venous return problem;

Exclusion Criteria:

* Known allergy or known history of hypersensitivity to the components of the investigational device and related compounds;
* Currently participating in another clinical study that may interfere with the study;
* Diagnosed skin diseases and/or cutaneous alterations on the test region (feet) that may impair the study (for example tattoos, marks, burns, scars, etc.);
* Diagnosed diseases that may impair the study (including but not limited to: Diabetes, Arteritis, Phlebitis, etc);
* Under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.);
* Having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device;
* Having a stage of CVD C3 on the CEAP classification;
* Having had a traumatic or neurological history in the last 6 months;
* Wearing an orthopaedic insole made by a health professional;
* Having a significant and disabling lower limb pain;
* Having a significant and disabling back pain;
* Having a contraindication to wearing insoles;
* Pregnancy or intention to conceive during the study;
* Breast-feeding
MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.

Oocyte retrieval is a major event during in VITRO-fertilization, with or without sperm micro-injection. Initially done by laparoscopy with general anesthesia, the oocyte collection is now carried out by trans-vaginal controlled ultrasound puncture. This potential painful event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary, requires analgesia or anesthesia. General anesthesia is certainly effective in terms of collected oocytes. It remains, however, a heavy time consumer, with personal risks and distributor of anesthetic agents in blood or follicular fluid. These products could have a deleterious effect on early embryonic development or implantation. Few data are available concerning these risks in the literature. General anesthesia is still essential for pusillanimous patients or for patients with a heavy surgical past. Nitrous oxide is an inhaled gas with properties widely used in obstetric during parturition. It is regularly used during general anesthesia performed for oocyte retrieval. With a gas composed of 50% N2O and 50% O2, its main interest is to provide analgesia in a state of conscious sedation. The effects of nitrous oxide in this form had never been assessed on the clinical or biological Oocyte collection. We conducted a preliminary study to assess pain in patients receiving local anesthesia, according the current protocol. Thus, 44% of patients had severe pain (VAS\> 40/100) during or just after transvaginal oocyte retrieval. In our preliminary experience, immediate or distance post-operative pain was high and we plan to evaluate the benefit of analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective, randomized and controlled study as compared with local anesthesia associated to Alprazolam.

Eligibility Criteria:
Inclusion Criteria:

* patient requiring a first or second oocyte retrieval procedure for IVR or ICSI after ovarian stimulation by gonadotrophin
* agreement to participate to this study

Exclusion Criteria:

* absolute indication for oocyte retrieval with general anesthesia
* no agreement to participate to this study,
* painfully known patient-not easy ovarian vaginal accessibility for monitoring or puncture
* respiratory pathology-chronic liver, kidney pathology, immunodeficiency, -contraindication to the medications used during the protocol
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing aortic valve bioprosthesis implantation

Exclusion Criteria:

* mechanical heart valves in any position
Reference Values and Determinants of Hydration in Children 3-13 y

Purpose:

1. Develop reference values for hydration biomarkers for children of 3 to 13 years old
2. Explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y
3. Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y
4. Evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y
5. Examine the role of different foods and fluids on hydration in children (3-13 y) and parents

Recent studies in children have indicated that greater water intake and/or lower urine concentration are associated with better overall nutrition, increased physical activity, improved mood state, and enhanced cognition; which is specifically related to superior attention and memory when compared to sub-optimally hydrated children. Separately, ancillary water is being investigated as a potential treatment possibility for pediatric obesity. Although, causality cannot be directly confirmed, it is apparent that ample water intake in children, above and beyond the body's compensatory mechanisms, is preferable for psychological and physiological health. However, the prevalence of failure to meet water recommendations and hypohydration in children remains high. Still it is unclear if elevated hypohydration reports within the pediatric population are due to a general failure of children to meet water recommendations, or due to inadequacy of the published guidelines

Eligibility Criteria:
INCLUSION CRITERIA:

* Boys and girls aged 3-13 years old
* Parent willing to participate as a subject as well
* Parents: aged 20-50
* Children and parents willing to collect urine samples and store them at room temperature
* Avoid strenuous exercise on day of collection
* Parent: included if \>50% of grocery shopping, food preparation, and feeding is handled by this parent

EXCLUSION CRITERIA:

Parents \& Children:

* Evidence of clinically relevant metabolic, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrine or psychiatric history of disease, based on the medical history questionnaire
* Use of medication that interferes with water metabolism
* Surgical operation on digestive tract (e.g. bariatric surgery), except possible appendectomy
* Regular drug treatment within 15 days prior to start of the study
* Not willing to refrain from exercise on the day before and during urine collection
* Unwilling to collect urine
* Inability to participate in the entire study
* Pregnancy for females

Children:

* Use of Diapers
* Enuresis or use of nappies during the day or during the night
Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients

The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18 - 80 years (inclusive) of age
* Clinically and genetically diagnosed as OPMD
* Moderate dysphagia (abnormal drinking test at screening and on the first dosing day, before drug administration)
* Patients who provide written informed consent to participate in the study
* Body Mass Index (BMI) \<30 kg/m2

Exclusion Criteria:

* Diabetes mellitus type 1 or 2
* Other major diseases, e.g.: renal failure (creatinine clearance \<60ml/min), liver failure and chronic liver diseases (e.g. hepatitis B or C) , HIV carriers, tuberculosis, SLE, rheumatoid polyarthritis, sarcoidosis, collagenosis
* Uncontrolled heart disease , CHF,
* Other neuromuscular diseases
* Other disorders associated with esophageal dysphagia: e.g. severe gastroesophageal reflux (GERD), esophageal stricture due to mechanical or chemical trauma, infection (e.g. esophageal moniliasis), drug-induced dysphagia (e.g. bisphosphonates), esophageal rings and webs, spastic motility disorders of the esophagus.
* History of malignancy (except non-invasive skin malignancy)
* History of neck irradiation
* Pregnant or currently lactating women
* Obesity (BMI≥ 30) and associated morbidity
* Prior pharyngeal myotomy
* Weight loss of more than 10% in the last 12 months.
* Known hypersensitivity to any ingredients in the injection
* Patient receiving anticoagulant treatment (e.g. warfarin)
Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections

The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.

Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe infections. Although flu was primarily considered as limited to the respiratory system, clinical reports suggest its association with organ involvement outside of the respiratory tract.

The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adults ≥18 years old
* Flu or RSV infection confirmed by multiplex qPCR on nasal swab
* Oral non-opposition

Exclusion Criteria:

* No health insurance
* Co-infection with viruses other than influenza or RSV
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

* Active or untreated central nervous system metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Severe infection within 4 weeks prior to randomization
* Significant cardiovascular disease
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

* Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
The Physiological Effect of High Flow Oxygen Therapy

Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.


Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients with acute hypercapnic respiratory failure

Exclusion Criteria:

* other lung/pleural diseases or thoracic deformity
* severe heart failure (New York Heart Association class IV), severe dysrhythmia
* unstable angina, or malignant comorbidity
* obesity (BMI ≥ 35 kg/m²)
* severe obstructive sleep apnea syndrome
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.

Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin type \<IV (37),
* Have sustained a thermal burn injury,
* Have at least 2 independent sites that show clinical evidence of HSc,
* Are 2 months or more post-injury.

Exclusion Criteria:

* Subjects with skin phototypes IV or higher,
* With history of keloidal scarring,
* Who have coagulation disorder,
* Are taking immunosuppressive medications,
* If the mechanism of injury is an electrical, chemical, or cold injury,
* Any underlying active skin disease,
* Have taken oral Isotreinoin within the last 6 months,
* Photosensitivity or have taken photosensitizing medications,
* Pregnancy,
* Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer

This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management.


Eligibility Criteria:
Inclusion Criteria:

* Participants were patients who met the following predefined eligibility criteria: Ages 20-40; Overweight or obese; The pathological diagnosis was EC (endometrioid, grade I, no myometrium invasion or metastasis). Not pregnant; Be willing to comply with test requirements after being fully informed of all risks and inconveniences associated with the test.

Exclusion Criteria:

* Recurrent or metastatic disease; Currently participating in regular exercise at least 2 days per week; Pregnant at the start of the study; Or unwilling to comply with research requirements. Patients also completed the Physical Activity Readiness Questionnaire (PAR-Q) through a telephone interview. Patients with one or more potential exercise-related safety risks were excluded.
Implement and Test Visual Consent Template and Process

The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.


Eligibility Criteria:
Eligibility Criteria for Patients:

* Adult participants (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill. The eligibility criteria for the main trials are below:

  * UNC:

    * Basal-like PDAC Treated with Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) trial inclusion criteria:

      * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
      * Participant is willing and able to comply with study procedures based on the judgment of the investigator.
      * Age ≥ 18 years at the time of consent.
      * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
      * Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
      * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  * Washington University:

    * Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)

      * Participants of the Knight Alzheimer Disease Research Center.
      * Participants with available results from an Alzheimer Disease blood biomarker test.
      * Participants who agreed to be contacted for additional research studies.
  * University of Utah:

    * Huntsman Cancer Institute Total Cancer Care

      * Participants who have been diagnosed with any type of tumor or cancer.
      * Participants with genetic predispositions or family history of cancer or tumors.
      * Participant volunteers willing to share samples and data for research.

Eligibility Criteria for Research Staff:

* Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.
Lower Limb Resistance Training in Older Inpatients

The primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.

This is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit.

Feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. There are two groups (i) exercise intervention and (ii) control. It will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design.

The study will be based in St James's Hospital, Dublin. Assessments and the delivery of the exercise intervention will be conducted in the Physiotherapy department.

Patients will be recruited in the inpatient setting. Appropriate patients will be approached, and the intervention explained to them. The patient will be given an information leaflet and 24-hours to consider involvement in the study

Eligibility Criteria:
Inclusion Criteria:

* Patients, male and female elderly inpatients 65 years.
* Patients must be medically stable.
* Patients who are able to follow one-stage commands.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Unstable medical condition.
* Patients who are unable to follow one-stage commands.
* Acute pain or fracture
* Patients who are unable to stand or require more than assistance of two staff to mobilise/transfer.
* Patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.