cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle

Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure (SCP). Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion, such as a cyst or stress fracture confirmed by diagnostic imaging in the foot and/or ankle joint. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete validated patient reported outcomes measures pre-operatively including the Foot Function Index (FFI) revised short form, the EQ-5D™ and numeric pain score. These measures plus a subject satisfaction survey will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Screening for adverse events and revision surgeries will occur throughout the study.

Target enrollment is 140 patients at up to 25 clinical sites. Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Eligibility Criteria:
Inclusion Criteria:

* Subject has at least one bone defect such as a bone marrow lesion (BML), cyst or stress fracture confirmed by diagnostic imaging
* Surgeon considers the patient appropriate for the SCP procedure
* Subject provides voluntary signature on the Institutional Review Board (IRB) approved Informed Consent
* Subject is at least 18 years of age
* Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail

Exclusion Criteria:

* Subject is pregnant at the time of surgery
* Subject is incarcerated
* Subject is involved in active litigation related to the condition being treated
Psychological Intervention for Caregivers of Patients With Malignant Gliomas

This research study is evaluating a psychological intervention for caregivers of loved ones with malignant gliomas.

Caregivers of loved ones with malignant gliomas frequently experience a physical and psychological burden caring for their loved ones. The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.

The psychological intervention will take place in a series of six sessions. A trained social worker or psychologist will meet with the participant or talk with the participant over the telephone or by video conference for 45 minutes at a time to discuss the caregiver experience while developing effective skills to support the loved one as well as the participant over the course of the loved one's illness.

Upon the completion of the sessions, the investigators will have a short (30-minute) exit interview to obtain the participant's feedback on the intervention. The investigators will use the feedback to improve the intervention before further testing its effectiveness in future research studies. The investigators will also ask the participant to complete questionnaires before and after their participation in the intervention to help the investigators understand the participant's coping skills, caregiving burden, mood, and understanding about the loved one's illness.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Identified by a patient with a malignant glioma (WHO Grade III or IV glioma) as the patient's primary caregiver
* The patient is receiving care at the MGH Cancer Center
* The patient was diagnosed with a malignant glioma within the past 6 months
* Able to speak and read in English
* Generalized Anxiety Disorder 7-item (GAD-7) score ≥5
* Participants may or may not be pregnant.

Exclusion Criteria:

* Deemed inappropriate for the study by the patient's clinician or the study PI
An Evaluation of the Usability and Usefulness of a Multi-language Online Patient Education Module

The purpose of this study is to determine if multi-language patients will find the multi-language capabilities of the online modules useful for better understanding of the general information regarding radiation therapy.

Research shows that treatment-related information is the most important informational need of cancer patients and online media sources are gaining popularity as a cancer communication method. It is important to know whether having multi-language online education modules are usable for and beneficial to the multicultural cancer patient population at Sunnybrook Hospital, given that recent research suggests that this cancer population in general faces many barriers to effective online cancer communication. Approximately 10 new patients from the radiation oncology clinic at Sunnybrook Hospital will be screened to participate in the study. Usability testing will involve a combination of interviewing, observation, think-aloud methodology and a short survey.Results will be analyzed by assessing the percentage of patients identifying with a certain level of the Likert scale on the survey as well as through content analysis of responses to the interview and open-ended survey questions.

Eligibility Criteria:
Inclusion Criteria:

* first/second language in one of the module languages with the ability to understand and communicate English to an understandable degree, basic computer skills, and the ability to complete 20-30 minutes of testing.

Exclusion Criteria:

* inability to participate in 20-30 minutes of usability testing.
Non-invasive Quantification of Muscle and Liver Glutathione GSH-MRS

Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized in the liver during the postprandial phase, which establishes a stock that is mobilized for the other tissues (muscle)during the postabsorptive period. It is of common knowledge that the decrease in glutathione concentrations associated with ageing could be involved in the development of the degenerative pathologies linked to the old age. These changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous synthesis of GSH. The development of nutritional strategies aiming at an improvement of the status glutathione requires the determination of its concentration within tissues, where it is active. The quantification of tissue concentrations of glutathione by biochemical techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method to quantify muscle and liver glutathione.

The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS. The accuracy of the method will be assessed from intra and inter-volunteer measurements. 1H MRS measurements will be performed with the Magnetic Resonance Imaging (MRI) 3 Tesla system of the Hospital, twice for each volunteer.

Prior to the measurements, volunteers will have a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center.

Eligibility Criteria:
Inclusion Criteria:

* - Healthy Volunteers, men or women, from 18 to 35 years old
* Having filled the questionnaire of compatibility in the MRI and having no contraindication in the MRI
* Having given their written, free and informed consent
* Affiliated with a social security system
* 19 \< BMI \< 25 kg.m-2

Exclusion Criteria:

* - Age \< 18 ans ou \> 35 ans
* BMI \< 19 ou \> 25 kg.m-2
* Carrier of a pacemaker, cochlear implants, metallic implants or magnetic element (cf questionnaire of compatibility in the MRI, Appendix 3)
* Under treatment with repeated doses of paracetamol during the 2 weeks preceding the inclusion
* Under treatment in N-acetylcysteine during 2 weeks preceding the inclusion
* Regular sporttraining \> 3 hours / week
* Claustrophobia
* Difficulty of being immobile
* Pregnant women or women who are breast-feeding
* Incapacitated legal (private person of freedom or under guardianship)
* People who cannot be followed and/or compliant in the requirements of the study for psychological, social, family or geographical reasons,
* People already included in another clinical trial
Evaluation of the Effectiveness of a Guidance Program for Parents of Deaf Children

The purpose of this project is to evaluate the effectiveness of a parent guidance program on (1) the parent's communication skills, (2) the parent's sense of competence and (3) the child's language development. Concretely, 11 guidance sessions will be offered to parents by alternating two group sessions (in a common place) and one family session (at home). These sessions will be given every week and will last approximately 2 hours. The sessions will focus on working on and learning adult attitudes conducive to the development of communication and language in the child. These sessions will be interactive through questions (wooclap), exchanges, video illustrations, role playing, etc. A practical application will be proposed in daily life with the help of the video-feedback technique during the home sessions, individually with the parent.

The effectiveness of this intervention will be evaluated via a pre- and post-test conducted in the families' homes. Episodes of parent-child interactions in a play situation will be filmed and coded in order to assess the parents' communication skills (receptivity, reactivity, language support strategies, etc.). The feeling of parental competence as well as the child's language will be estimated using parent questionnaires.

The investigators hypothesize that parent guidance sessions will have an effect on the communication skills of parents of deaf children and will indirectly improve their sense of parenting competence as well as the child's language development. This study will therefore offer avenues for adapting the support of families of deaf children.


Eligibility Criteria:
Inclusion Criteria:

* deaf children and parents
* 18 months - 4 years

Exclusion Criteria:

-
Thorough Flushing Strategy During Colonoscopy Examination

The investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.

Most physicians do not adopt a strategy of complete suction of fluid from the intestinal lumen during colonoscopy. There are both concerns about the time required for colonoscopy and the possibility of inability to thorough cleannig up. Some endoscopists believe that the visual field for partial cleaning of fecal water is acceptable and does not affect observation. This study aims to make an observation and comparison based on the existing problems mentioned above. With the help of direct water injection system, the investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.

Eligibility Criteria:
Inclusion Criteria:

* People without contraindications for colonoscopy

Exclusion Criteria:

* Patients diagnosed with colon polyps
Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France

Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.


Eligibility Criteria:
Inclusion Criteria:

* 1st Line Consultation in Pediatric Emergencies
* All reasons for consultation during working hours
* Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age

Exclusion Criteria:

* Refusal of participation by parents/child of decision age
* No membership of a social security scheme (beneficiary or entitled)
* No understanding of French
Spirituality, Religiosity, and Immune Functioning

The purpose of this study is to determine whether religiosity and spirituality are related to immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill cancer patients.


Eligibility Criteria:
Inclusion criteria:

* Inpatient at Calvary Hospital
* Diagnosis of terminal cancer
* Score of 20 or above on Mini-Mental State Exam

Exclusion criteria:

* Presence of a psychiatric disorder that would preclude the production of meaningful data
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[BID\] for 2 weeks and once daily \[QD\] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-breast-feeding females ≥18 years old.
* Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.
* Willingness to undergo sigmoidoscopy.

Exclusion Criteria:

* Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease).
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.
* Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.
* Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.
* Participant took diuretics with cardiac glycosides.
* Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination.

The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had received at least one dose of the study vaccine in the primary study
* Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
Evaluation of Performance of New IFIS Sleeve

A silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.

Cataract surgey is a common operation approximately 25 million pocedures per year worldwide. An essential step of the procedure is hydrodissection where fluid is forced into the eye through a cannula to free the cataract from its capsule. A serious and potential sight threatening complication of hydrodissection is iris prolapse, where the iris comes out of the wound. The overall incidence of iris prolapse during cataract surgery is 0.9% and higher in patients with intraoperative floppy iris syndrome (IFIS) at 11.9% , small pupils and small eyes. Patients on Tamsulosin medication with a Full Set of Project Data IRAS Version 6.3.3 5 DRAFT pupil less than 7.5mm have a 79% risk of prolapse Iris prolapse most often occurs during hydrodissection because the hydrodissection cannula is smaller (approx.1mm) than the wound (2.2-2.7mm) it is introduced through. Therefore the iris can be forced out / prolapse through this gap by the forced injection of fluid.

Traditional methods such as phenylephrine injection into the eye have varying effects can be unlicensed and possibly increase the prolapse risk. Mechanical pupil stretching can permanently damage the iris with complications.

Phacosleeve hydrodissection where the wound is sealed by a phacosleeve and the hydrodissecting irrigation cannula introduced through the sleeve or from side port /incison. The phacosleeve is not designed for this. This study is to use a purpose made tapered sleeve by Medicel in the same fashion as the current phacosleeve.

Eligibility Criteria:
Inclusion Criteria:

* patient with planned cataract surgery

Exclusion Criteria:

* pregnant woman
Analgesic Effect of Acupuncture for Patients With Rib Fractures

Traumatic rib fractures are common, resulting from significant forces impacting on the chest, and are associated with significant morbidity and mortality. Acute pain management in inpatients with traumatic rib fractures has been highly emphasized by practitioners. Inappropriate analgesia may cause respiratory complications, including pneumonia, atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be prevented or reduced by good analgesic therapy. This study is aimed to investigate the analgesic effect of acupuncture on traumatic rib fractures.

This open-label, randomized controlled trial will involve 150 patients who have traumatic rib fractures. Subjects are randomly assigned to acupuncture group, laser acupuncture group or sham laser acupuncture group with a 1:1:1 ratio. The intervention will be performed on the consecutive three day after allocation. Bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for each group. The traditional acupuncture group will be performed by inserting needles to a depth of 15-35 mm and last for 15 min. The laser acupuncture will be performed with the gallium aluminum arsenide LaserPen, which delivered 0.375 J of energy at each of the acupoints. Subjects in the control group underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the laser acupuncture group.

Eligibility Criteria:
Inclusion criteria

* Chest trauma
* Presence of one or more, unilateral or bilateral rib fractures diagnosed with chest X-ray
* Maximal rib pain score of more than 5 obtained using the numerical rating scale (NRS: 0-10)
* Ability to describe the sites of pain and evaluate the pain intensity accurately

Exclusion Criteria:

* Unable to describe the sites of pain and evaluate the pain intensity accurately
* There are open wounds on the sites of acupuncture points
* Severe multiple trauma or any poorly controlled diseases such as atelectasis, pneumonia, or other infectious diseases, immune system dysfunction, bleeding tendency, psychiatric disorders, and skin problems
* Receive surgical management of rib fractures
Lendormin D® Tablet (Drug Use Result Survey)

Study to investigate the safety and the efficacy in patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with insomnia

Exclusion Criteria:

* none
A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
* No prior chemotherapy for lung cancer.
* Patients must have at least one uni-dimensionally measurable lesion.
* Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

* Treatment with any drug within the last 30 days that has not received regulatory approval.
* Serious cardiac condition.
* Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
* Presence of fluid retention that cannot be controlled by drainage.