cyrilzakka/clinical-trials huggingface dataset:
Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)

The Mindfulness, Nutrition and Exercise to Optimize Resilience (MENTOR) program is offered through the National Center on Health, Physical Activity and Disability (NCHPAD). NCHPAD is funded by the Centers for Disease Control and Prevention (CDC), is a public health practice that offers health promotion programs and resources to people with mobility disabilities. The purpose of this project is to provide a free-of-charge wellness program designed to improve health and wellness for people with mobility and physical disability living in the United States.

The objective of the MENTOR program is to improve wellness for people with mobility limitations. MENTOR is a free, 8-week program focusing on physical, mental, and emotional health for individuals with an existing disability or a recent diagnosis. The program provides core information on mindfulness, exercise, and nutrition. Participants get one-on-one health coaching and access to a fitness instructor, registered dietician, and mindfulness coach. The classes are virtual, and the exercise equipment needed for the classes will be mailed to participants.

The research question is to measure the effectiveness and implementation of the MENTOR program.

Participants will be asked to fill out an eligibility sign-up form on NCHPAD. If eligible, they will be consented by Shirley Ryan AbilityLab (SRAlab) via REDCap. On the same SRAlab REDCap survey link, after the consent form, they will be able to complete an interest form. If selected, participants will be asked to complete 3 surveys through NCHPAD Connect before the MENTOR program begins.

Once the 8-week MENTOR program is complete, you will be asked to complete a post-program survey for NCHPAD about your experience, and a post-program implementation survey through SRAlab.

Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States
* People 18 years or older
* A self-reported physical disability/mobility limitation (or use an assistive device such as an ankle foot orthosis, cane, walker, scooter, or wheelchair).
* Have internet access and a mobile device (phone, tablet, laptop, desktop) to attend sessions.

Exclusion Criteria:

* Younger than 18 years old
* Living outside of the United States
* No physical disability/mobility limitation
* No internet access
Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome

The purposes of this study were to assess Quality of Life (QoL) and urination urge, incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment with propiverine.

The drug being tested in this study is called propiverine. Propiverine is being tested to evaluate Quality of Life (QoL) and improvement of OAB symptoms in people who take propiverine. The study will enroll approximately 1000 patients who the treating physician decided to treat with propiverine 15mg tablets or 30 mg regulated release capsules as part of their normal clinical practice. All participants will be asked to keep a voiding diary for 2 consecutive days and to complete a QoL questionnaire after 1st visit and before each subsequent visit. This multi-centre trial will be conducted in Belgium. The overall time to participate in this study is up to 12 weeks. Participants will make 3 visits to their healthcare provider.

Eligibility Criteria:
Inclusion Criteria:

* 1. Written informed consent. 2. At least 18 years of age. 3. Patients with complaints of Overactive Bladder Syndrome (OAB) without urge incontinence, OAB with urge incontinence, or with mixed urinary incontinence. 4. Patients who consult their GP or an urologist for the first time with these complaints or who stopped their OAB treatment since at least one month. 5. Receiving a propiverine prescription according to the Summary of Product Characteristics (SPC).

Exclusion Criteria:

* None, as per the SPC contra-indications
Metagenomic NGS for Diagnosis of Pneumonia

In this randomized controlled trial, we aim to evaluate the efficacy of incorporating mNGS in the management of pneumonia on efficiency and accuracy of causative pathogen identification, proportion of participants with effective antimicrobial therapy, length of hospitalization, and mortality.

This is an open-label, randomized, multi-center, phase 2 study that will evaluate the efficacy of incorporating mNGS in the management of severe pneumonia on accuracy and efficiency of achieving definite diagnosis of identifying causative pathogens of pneumonia, appropriate antimicrobial therapy and patient outcomes. The diagnosis of pneumonia requires radiological evidence of pneumonia and at least two of the following clinical criteria: new, or worsening cough, new or worsening expectoration of sputum, new or worsening dyspnea, hemoptysis, pleuritic chest pain, and fever (≥38.0°C). Severe pneumonia is defined as pneumonia with hypoxemia requiring orotracheal intubation and mechanical ventilation support.

Written informed consent is needed from the eligible subjects or from their legal guardian at the time of recruitment. After completing informed consent, subjects will be randomized with a 1:1 allocation ratio via a web-based randomization system to receive standard of care (SOC) using culture and serology based work-up for pathogen detection or SOC with additional mNGS method using APGseq ® (Asia Pathogenomics, New Taipei City, Taiwan) for pathogen detection. The treatment for pneumonia is suggested following the Taiwan Guidelines for the Management of Pneumonia published in 2018. After randomization, the subjects will be followed until death, discharged from the hospital or 28 days after randomization whichever comes first. The total study duration is expected to be two years from the first subject enrolled to the final analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Presenting to the ICU with a diagnosis of pneumonia (fulfilled with both radiographic and clinical criteria)
2. Adults aged ≥18 years
3. Orotracheally intubated
4. ICU admission for \<24 hours
5. APACHE II score \<35 on ICU admission

Exclusion Criteria:

1. Life expectancy below 4 weeks
2. With an existing directive to withhold life-sustaining treatment
3. Patients not willing or able to provide a lower respiratory tract sample at ICU admission
4. Previous work-up has identified specific pathogens which can account for the index event of pneumonia
5. Multiplex PCR or NGS testing has been done for pathogen detection before screening
Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia

Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.

The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18
* Having a cerebral infarct consecutive to a wide calibre arterial occlusion
* taken care for mechanical thrombectomy

Exclusion Criteria:

* Patient benefiting from a legal protective measure
* Pregnant or breast-feeding woman
* Opposition of the patient to participate in the study
A Study of Virtual Reality During Urological Procedures

This research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs.

Once participants are consented and checked in for the procedure, researchers will obtain the randomization assignment from a REDCap database with a randomization module designed by the study statistician. Participants will be randomized in a 1:1 ratio to either virtual reality or standard of care.

Researchers will collect participant vital signs (heart rate, blood pressure, and SpO2) at check in, laying down on the table, in the midst of the procedure, and after the procedure is complete. After the procedure is completed, all participants will be given two surveys about satisfaction with the experience to complete. Researchers will record any medications the participants takes the day of the procedure. Researchers will then gather demographic data from the participant's chart through Epic (age, height, weight, BMI, race, ethnicity, past medical history, and procedure information). All study data will be stored in a secure REDcap database. Researchers have teamed up with members of the anesthesia department at Mayo Clinic Florida who have performed similar studies utilizing the virtual reality headsets. The department has three virtual reality headsets and know how to operate them.

The participants who are selected to use the virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef.

Eligibility Criteria:
Inclusion Criteria:

- Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.

Exclusion Criteria:

- Anyone \< 18 years of age.
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
* tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
* No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
* No more than two restorations will be placed per patient

Exclusion Criteria:

* Sensitive teeth
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and/or rampant caries
* Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
* Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
* Patients unable to return for the recall appointments
Combined Spinal/Epidural (CSE) Saline Duration/Spread

An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 12 years of age
* ASA status 1 or 2
* cervical dilation \< 6cm

Exclusion Criteria:

* ASA assigned 3 or 4
* advanced labor (\> 6cm cervical dilated)
* distorted epidural anatomy
Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

The purpose of this study is to clarify the changes of neurocognitive function of patients undergoing cardiac valve disease before and after surgical treatment under cardiopulmonary bypass operation, and to predict the neurological prognosis of such patients through combined imaging technology, so as to improve and avoid the occurrence of postoperative neurological dysfunction in such patients.

This study focuses on brain protection in patients with heart disease. The preoperative brain imaging and consciousness and cognition evaluation results, intraoperative brain monitoring indicators, adverse events of neurological function, brain imaging and consciousness and cognition evaluation results during the postoperative and follow-up periods were recorded. At the same time, serum markers related to perioperative neurological function were obtained to explore the relevant factors affecting neurocognitive function during the perioperative period. The research objectives to investigate the perioperative changes of neurocognitive function in patients undergoing heart valve surgery under cardiopulmonary bypass and the related factors affecting the prognosis of neurocognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Aged 45-80 years old.
* Accept heart biological valve replacement or heart valvuloplasty.
* More than 6 years of Education.
* At baseline, the score of Mini-mental State Examination (MMSE) scale is more than 23 points

Exclusion Criteria:

* Patients who failed to obtain informed consent.
* Preoperative diagnosis of stroke, epilepsy, history of craniocerebral surgery, cerebrovascular disease, psychosis and rescue patients with cardiopulmonary resuscitation before operation.
* Alcoholism, illiteracy and left-handed.
* There was severe organ hypoperfusion or organ dysfunction before operation, including: preoperative myocardial infarction \< 90 days, renal failure or dialysis, severe liver injury, digestive tract ischemia, spinal cord ischemia and iliac artery occlusion.
* There are contraindications to magnetic resonance examination, such as claustrophobia and metal implants in the body.
* Pregnant or lactating women.
* Participating in other clinical studies will affect the main indicators of this study.
A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.

This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.

In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.

The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older,
2. Patient with a metastatic solid tumor,
3. Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
4. Measurable disease according to RECIST 1.1 and iRECIST criteria,
5. Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
6. Disease progression with immunotherapy (progression assessed by iRECIST criteria) but having received at least 6 months of immunotherapy,
7. Performance Status (PS) of 0 or 1,
8. Patient eligible for stereotactic radiotherapy,
9. Patient affiliated to or benefiting from a social security scheme,
10. Patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures,
11. Patient willing and able to undergo all examinations and procedures in accordance with the clinical investigation plan.

Exclusion Criteria:

1. Patient having received previous radiotherapy since the start of immunotherapy,
2. Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
3. Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment,
4. Patient with hematological cancer,
5. Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
6. Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
7. Pregnant or breast-feeding women,
8. Patient under legal protection.
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects with Notalgia Paresthetica

This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).

Study to assess the efficacy and safety of CLE-400 topical gel applied once daily for the treatment of moderate-severe chronic pruritus in adult subjects with NP. The study comprises a screening phase of up to 37 days, including a 7-day run-in period, a 4-week double-blind treatment period, and a 2-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of Notalgia Paresthetica.
* Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica.
* Subject has moderate to severe pruritus.
* Subject is able and competent to read and sign the informed consent form (ICF).

Exclusion Criteria:

* Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica.
* Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results
* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Stoma Closure and Reinforcement Trial ll

Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18years.
2. Patient is undergoing closure of loop ileostomy.
3. Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy.
4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery.

Exclusion Criteria:

1. Pre-existing systemic infection at the time of ileostomy takedown
2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
3. Previous abdominal hernia repair with mesh placement
4. Concurrent surgical procedures in addition to closure of diverting loop ileostomy
5. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors

This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.


Eligibility Criteria:
Inclusion Criteria:

* History of biopsy proven neuroendocrine tumor including (but not limited to): gastrointestinal NET, pancreatic NET, pulmonary NET, NET unknown primary, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
* At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with SUVmax \> SUV meanliver).
* Age greater or equal to 40
* Ability to provide written informed consent prior to participation in the study

Exclusion Criteria:

* Weight \> 225 kg (weight limitation of PET/CT scanner)
* Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
* Any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
* Previous allergic reaction to 18F-DOPA
* Lack of intravenous access
* Pregnant
* Breastfeeding
* Less than 40 years old
Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.

Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of unilateral ischemic Stroke
* Unilateral hemiplegia resulting from Stroke
* Evolution of at least 6 months since the Stroke
* Age between 35 and 81 years of age
* Presence of hypertonia in the upper extremity
* Restricted shoulder range of motion

Exclusion Criteria:

* Recurrent Stroke
* Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
* Cognitive deficits
* Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
* Belonephobia (fear to needles)
* Have received pharmacological treatment for shoulder pain 3 months before the study
* Existence of peripheral nerve injury
* Previous history of fracture in the gleno-humeral joint
* Episodes of epilepsy in the year prior to participation in the study