cyrilzakka/clinical-trials huggingface dataset:
FallsTalk Falls Prevention Program for Caregivers and Persons With Memory Loss or Dementia

This randomized-control trial involves dyads consisting of a family caregiver (CG) and a person with memory loss or dementia (PwD). The FallsTalk Caregiver Resource System (FT-C) intervention is administered by the CG, whose role is to modify their interactions with the PwD. FT-C will create a 3-way partnership between an Interventionist and the dyad, capitalizing on CG-PwD interactions. The PwD will be observed by the CG and both will be evaluated by the study team. Brief daily FT-C intervention by the CG will stimulate the PwD's awareness and individualized weekly CG- check-ins with the Interventionist will increase the CG's skills. Our hypothesis is that FT-C will increase PwD's awareness of personal fall threats and encourage new falls prevention behaviors, resulting in reduced fall rates.

This is a single-site preliminary trial enrolling dyads in Western Washington state only.

Eligibility Criteria:
Caregiver (CG) Inclusion Criteria:

* residence in western Washington state
* minimum age= 18
* family CG
* primary CG
* some daily personal contact with Person with Dementia (PwD) for 1 month
* basic computer skills and telephone access
* able to commit to 6 month study.

Persons with Dementia (PwD) Inclusion Criteria:

* living at home with residence in western Washington state
* minimum age= 55
* at least one fall in last 6 months or regular loss of balance
* can ambulate at least 6 feet
* ability to communicate thoughts
* willingness to participate.

CG Exclusion Criteria:

* Professional CG (unless primary CG for family member)
* distance CG unable to be physically present with PwD daily for 1 month
* terminal illness with less than 6 months to live
* CG has significant memory loss.

PwD Exclusion Criteria:

* Residence outside of western Washington state
* Living in Residential care setting
* non-communicative
* terminal illness with less than 6 months to live
* wheel chair or bed bound.
Remote Assessment of OCT Scans for BCC Detection

Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Underwent OCT scan and punch biopsy for lesions suspect for BCC

Exclusion Criteria:

* Unable to sign informed consent
Hyponatremia in the Prevention of Hospitalized Patients Falls

Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Aims:

1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.
2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention.

Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B).

The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance \*\* and 124 patients receiving the experimental intervention \*, if necessary, by participant Unit).

Data collection: In each of the study participants Units both interventions will be held. First the participants Units have been randomized in two groups (Group A: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will be potentially included. First of all, collaborators will give them an informed consent to ask for their participation.

The interventions are:

* Experimental intervention: early diagnosis, treatment of hyponatremia until resolution and valuation according to the Dynamic Gait Index test. Duration: 6 months
* Habitual action: the usual pattern of work will be performed in all patients who enter. Duration: 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Admitted to a participating study unit
* Wish to participate in the study and signature of informed consent.

Exclusion Criteria:

* Transfer of the patient to a unit not included in the study
* Deterioration of the patient's condition to severe or extremely painful
Multimodal Modeling of the Knee Joint

The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).

The source population will consist of at least 50 patients whose following modalities of images of the leg are present in the database: scanner, MRI, radiography. No restrictions on age or gender are required.

A dedicated algorithm adapting statistical models of appearance to the specific morphology of the patient acquired through an MRI and / or scanner and radios will then be developed.

Eligibility Criteria:
Inclusion Criteria:

* Patients having the 3 modality of images : scanner, MRI, radiography
* Patients having osteoarthritis or knee trauma
* Images showing the articualtion of the knee
* having formulated his non opposition

Exclusion Criteria:

* Presentation of a partial view of the knee or any view that does not allow a good segmentation of the total knee joint.
* Refusal to participate
Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.

In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for curative surgery between 18 to 80 years old;
* American Society of Anesthesiologists(ASA) grade I-III;
* Pathological diagnosis of adenocarcinoma;
* Tumor located between the cecum and sigmoid colon;
* Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
* Informed consent;
* No preoperative chemoradiotherapy;
* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

* Pregnant patient;
* History of psychiatric disease;
* Use of systemic steroids;
* Simultaneous multiple primary colorectal cancer;
* Preoperative imaging examination results show:

  1. distant metastasis;
  2. unable to perform R0 resection;
* Postoperative pathology of T1-T2 N0;
* History of any other malignant tumor in recent 5 years;
* Patients need emergency operation: mechanic ileus, perforation.
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay

The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.

The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.

The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay through a multi-site, method comparison on prospectively collected, left-over enriched Lim broth specimens.

Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

1. An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
2. Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
3. The specimen is from a female patient who is at 35 - 37 weeks gestation.
4. The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
5. Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
6. The specimen is received in good condition (no leakage or drying of the specimen) and was accepted for testing by the site in accordance with established laboratory procedures.
7. The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.

Exclusion Criteria:

1. The specimen was collected at a site which is not covered under the study IRB.
2. The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
3. The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
4. The specimen was enriched in Lim broth for \<18 hrs or \>24 hrs.
5. A swab specimen that cannot be placed in Lim broth within 4 days of collection.
6. Inconclusive latex agglutination results - weak agglutination, agglutination that occurs in more than one latex reagent or the results are otherwise considered inconclusive based on established laboratory procedures or the instructions included with the latex agglutination test kit.
7. Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
Performance Comparison Between Masimo W1™ and Apple Watch Series 8

This study is also designed to compare the performance of Masimo W1™ and Apple Watch Series 8 against FDA cleared hospital grade pulse oximetry technology under desaturation conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 55 years of age.
* Subject is American Society Anesthesiologist status 1 (ASA I)
* Subject has a BMI between 18 and 35.
* Subject is able to read and communicate in English and understands the study and the risks involved.

Exclusion Criteria:

* Subject is currently taking any medications which in the opinion of the principal investigator would not be suitable for participation in the study.
* Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails that can interfere with study device's placement.
* Participants with conditions or skin abnormalities at or around site of sensor placement that could affect the placement on the sensor or prevent monitoring of physiological parameters during the study, such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown.
* Subject has participated in an investigational drug study within one month prior to the start of the study.
* Subject has failed the Allen's Test to confirm patency of the collateral artery.
* Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination.
* Subject has a positive urine cotinine or drug test.
* Subject has a reported allergy to Lidocaine.
* Subject has clinically significant anemia or other hemoglobinopathy.
* Subject has a room air saturation of less than 95% by pulse oximetry.
* Subject has a clinically significant abnormal EKG.
* Subject has a clinically significant abnormal pulmonary function test via spirometry.
* Subject is intolerant to a breathing mask apparatus.
* Subject has a COHb greater than 3%, or MetHb greater than 2% verified by laboratory co-oximeter.
* Subject has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
* Subject is unwilling or unable to provide informed consent or comply with the study procedures.
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) I and II with one of the risk factors a-d

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* CS (PS) III and IV
* Written informed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
Platelet-rich Plasma for Menical Tear

Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Platelet-rich-plasma (PRP) has been shown to be effective in accelerating wound healing and tissue regeneration in orthopedic and oral surgery. This clinical trial aims to investigate the safety and efficacy of intraarticular and periferal PRP injection in patients with stable meniscal injury. The pre- and post-interventional clinical outcomes will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients 18-70 years of age
* With diagnosis of meniscus injury
* Single tear of the medial and/or lateral meniscus
* With no indication of meniscus repair surgery

Exclusion Criteria:

* Prior history of multiple ligaments injury, associated significant ligament instability: Grade III MCL, Grade III PCL, or ACL deficient knee
* Prior history of knee surgery
* Discoid meniscus
* Osteoarthritic changes (Kellgren Lawrence scale \>2)
* Inflammatory diseases (i.e. rheumatoid arthritis)
* Underlying bleeding disorder or coagulopathy
* Concominant chondral defects (\> 2 ICRS)
* Cancer patients
* Pregnancy
* Patients who will not cooperate with six-month followup
A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years.
* Active subfoveal choroidal neovascularization (CNV) due to AMD.

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
* Subjects with subfoveal scar or subfoveal atrophy
* Any ocular or periocular infection in the past twelve (12) weeks.
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy

Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy.

The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images.

The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.


Eligibility Criteria:
Inclusion Criteria:

Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected colonic disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who need colonoscopy
2. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

1. Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
2. Patients with contraindication to colonoscopy including the paralytic ileus
3. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
4. Patient with contraindication to bowel cleansing preparation
5. Patients on cancer treatment (chemotherapy or radiotherapy)
6. Patients who need sedative colonoscopy
7. Patients who receives a therapeutic colonoscopy
8. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
9. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
10. Patients who have been exposed to NPO-13
11. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department

Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.

Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021).


Eligibility Criteria:
Inclusion Criteria:

* age: 1 months to 17 years
* sex: all
* with at least one access to the Pediatric ED of the hospital for seizures

Exclusion Criteria:

* children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting...).
Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)

Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease.

Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of its effects.

Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in a single-blind fashion. All patients receive therapy according to the current international guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. RemPostCon is started at the time of angioplasty in the infarct related artery. Primary endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if there are no contraindications.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 yrs AND Age =\< 80 yrs
* STEMI definition
* Pain to door time \< 6 hrs
* Killip class 1 - 2 - 3
* Initial TIMI flow 0 - 1 in the anterior descending artery
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Cardiogenic shock
* Initial TIMI flow 2 - 3 in the anterior descending artery
* History of prior MI in the past 6 months
* History of prior CABG
* History of peripheral vascular disease III - IV grade
* History of abdominal Aortic Aneurysm \> 5 cm
* Severe coronaropathy that could condition further revascularization before the end of the study
* Other relevant medical or surgical conditions that can influence prognosis at 4 months