cyrilzakka/clinical-trials huggingface dataset:
Low Vision Occupational Therapy in Parkinson's Disease

The primary aim of this study is to determine whether low-vision occupational therapy improves quality of life in Parkinson's Disease (PD) patients. Low-vision occupational therapy has not been previously studied in PD patients, and we suspect that this is a beneficial treatment option for PD patients as vision impairment is common in the PD patient population. Our primary objective will assess whether quality of life was improved following a low-vision occupational therapy session.

This project will be an exploratory study that will evaluate the benefits of low vision occupational therapy in the treatment of PD using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP) as the primary outcome measure. This tool assesses 33 vision-dependent ADLs ranging from personal care, leisurely activities, clothing management, meal preparation, etc. Patients are able to rank their ability to complete these tasks as independent, minimally difficult, moderately difficult, greatly difficult, unable, or not applicable. This will allow us to capture potential changes in the patient's ability to complete vision-specific ADLs following low vision occupational therapy. In addition, we will also evaluate quality of life using the Parkinson's Disease Questionnaire (PDQ-39), to compare this broad outcome measure with the R-SRAFVP.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* seen at UAB Movement Disorders Clinic
* diagnosis of idiopathic Parkinson's Disease
* able to read, speak, and understand spoken English.

Exclusion Criteria:

* minors
* cognitively impaired
An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection is confirmed on antigen test or PCR test
* Pulmonary infiltrative shadow is confirmed on chest X-ray test
* Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy

Exclusion Criteria:

* Continue treatment for Pneumonia before SARS-CoV-2 infection
* SOFA score \>= 15
* Infection type on DIC diagnosis criteria \>= 4
* Deep Venous Thrombosis
Effect of Low Level Laser Therapy After Wisdom Tooth Removal

The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal.

Each Patient will get all four wisdom teeth removed, left and right side separately. After the operation, low level laser therapy is applied intra- and extraorally. Two different lasers are used, one for each side. The two lasers look identical. Only one of the lasers has therapeutic light, the other one shows just non-therapeutic red light. The effect of the low level laser is measured by several parameters and they are compared with the other side. These parameters are pain, swelling and mouth opening. The selection of the lasers to the sides is double-blind and randomized.

Eligibility Criteria:
Inclusion Criteria:

* Indication for prophylactical wisdom tooth removal
* 4 wisdom teeth

Exclusion Criteria:

* pregnancy
* taking blood thinners
* known infectious diseases
* untreated diabetes mellitus
* taking immunosuppressants
* Previous infections in the area of the wisdom teeth
* smoking
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation

VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation.

Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on Catheter and Surgical Ablation for Atrial Fibrillation. Eligible patients will receive treatment with the VAS including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins.

Up to 100 patients will be enrolled at up to 10 sites in Europe (EU) and in the United States (US).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:

  1. Two or more symptomatic AF episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. An episode of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode.
  2. At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year
* Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
* Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
* Subject is able and willing to give informed consent.
* Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study

Exclusion Criteria:

* Prior LA ablation or surgery
* Persistent, longstanding persistent, or permanent AF
* AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
* NYHA Class III or IV congestive heart failure
* Rheumatic heart disease
* Atrial myxoma
* LVEF \<40% measured by acceptable cardiac testing (e.g. TTE, TEE)
* Anteroposterior LA diameter \>5.5cm or \<3.5cm by TTE, CT or MRI
* Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure
* Presence of pulmonary vein stent(s)
* Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70%
* Presence of pre-existing pericardial effusion
COVID-19 Immunologic Antiviral Therapy With Omalizumab

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.

Coronavirus disease 2019 (COVID-19) has affected over 88 million people, resulting in the death of at least 1.9 million individuals and numbers continue to climb exponentially. Despite these staggering numbers, there are currently very few effective treatments for COVID-19. The immune response to COVID-19 virus appears to follow 2 phases. During the incubation and early disease, interferon (ex. INF-α) signaling and adaptive immunity preclude the disease from progressing. If, and when, this immune response is impaired, the virus may cause pathologic inflammation leading to massive organ dysfunction leading to acute respiratory distress syndrome (ARDS).

Omalizumab is a humanized anti-IgE antibody approved by Health Canada for the treatment of moderate-severe asthma and chronic spontaneous urticaria. Omalizumab has been shown to exhibit antiviral and anti-inflammatory effects in virally exacerbated asthma cases that may be relevant to the treatment of COVID-19.

This is a double blind randomized placebo-controlled trial to evaluate the efficacy of a single dose of omalizumab in reducing all cause mortality at day 29 in severe hospitalized COVID-19 cases. Moreover, time to improvement/hospital discharge, incidence and duration of mechanical ventilation and safety will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Positive RT-PCR assay for SARS-CoV-2;
2. COVID-19 disease requiring hospitalization
3. Dyspnea at rest or during minimal activity (sitting, talking, coughing, swallowing), OR

   * Respiratory rate \> 22/min, OR
   * PaO2 \< 65mmHg or O2Sat \< 90%, OR
   * Infiltrate on chest radiography (CXR) (worsening CXR if baseline abnormal)
4. Age ≥18 years;
5. Ability to provide consent or to provide consent via a substitute decision maker

Patients who are pregnant may also be eligible if consent is provided. Patients who have received one of the SARS-CoV2 vaccines and/or bamlanivimab are eligible to participate in the study

Exclusion Criteria:

1. Known hypersensitivity to Omalizumab or its excipients
2. Inability to give consent themselves or via proxy
3. Patients who received Omalizumab or another anti-IgE molecule in the last 12 months
4. Patients receiving another monoclonal antibody to treat SARS-CoV-2/other indication prior to starting CIAO trial. However, once the study is initiated, if it is judged by the treating team/patient's doctor that patient's health/clinical status may benefit from a monoclonal antibody (e.g. tocilizumab), this will be allowed.
5. Patients who are below the age of 18
Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.

Delineation of radiation field

* Gross tumor volume (GTV): disease clinically visible / palpable
* clinical target volume (CTV): equal to GTV
* planned treatment volume (PTV):
* tumors ≤ 2 cm in diameter, with 5-10 mm CTV margin
* tumors\> 2-5 cm in diameter, with 15-20 mm CTV margin
* Marking the GTV and PTV pen back projection
* photograph of the treatment area
* protections of the normal structures with blocks of lead, if necessary

Technical

* Distance focus-skin Tube: 35 cm Locator: 30 and 40 cm
* Sizes Tube: 2, 3 and 4 cm in diameter Finder: 6x8 cm, 8x10 cm
* Energy:

  80 kV 140 kv
* Filter 80 kV, 2 mm Al 140 kv, 0.5 mm Copper
* Current Draw: 20 mA

Dose

* tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89
* tumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96

Clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cosmesis not important
* Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation
* Clinical stage I and II
* Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek
* Patient with up to 3 injuries eligible for the study
* Karnofsky Performance Status (KPS) ≥ 70%
* Age \> 18 years
* Informed Consent signed by the patient consenting to undergo the study

Exclusion Criteria:

* Indian Race
* Prior treatment for their skin cancer
* More than three synchronous lesions to treatment with RT
* Basal syndrome, xeroderma, vitiligo and albinism
* Immunosuppression
* Prior burn at the tumor site
* Tumor \> 5 cm
* Age \<18 years
* Carrier mental incapacity
* People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
The Relation Between Movement Patterns, Balance Performance, Function of the Inner Ear and Falls

Falls are one of the most common reasons for immobilisation and death in elderly population. This study aims at studying falls among a group of older people. The aim is to study the relation between movement patterns, balance performance, inner ear function and future falls. Senior member will be recruited through the non-profit association "Friskis\&Svettis. Measures of movement patterns, balance performance and innear ear function will be measured at baseline. Falls will be monitored through falls diaries, collected every third month during a 12 month period.

Falls are one of the most common reasons for immobilisation and death in elderly population. They will be even more essential to address when large birth cohorts grow older and life expectancy increases. Number of elderly persons is constantly rising. When in 2010 there was 1730 000 over 65-year olds in Sweden, the prognosis for year 2060 is 3221 000 persons. Hence, it is important to find solutions for preventing falls. The aim of this project is to study the relation between movement patterns, balance performance, inner ear function and future falls. After measuring movement patterns, inner ear function and balance at baseline, falls will be monitored through falls diaries, collected every third month during a twelve month period in a group of older persons, recruited through the non-profit association "Friskis\&Svettis" in Malmö, Sweden. The study population will consist of senior members in the association, invited to workshops about balance.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, 65 years and older
* The ability to ability to speak and understand Swedish language.

Exclusion Criteria:

* Age younger than 65
* Not able to speak and understand Swedish language
Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.

The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G\*power will be used body composition analyzer to calculate the percentage of fat.

Cross-sectional study was applied. Data was collected through a questionnaire (oswestry disability index arabic version). Fat percentage was taken by Body composition analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Excess fat mass
* Age must be over 18 years.

Exclusion Criteria:

* People under the age of 18.
* Low back pain not associated with increased fat mass.
Accuracy of Commercially Available Heart Rate Monitors in Athletes

The purpose of this research is to compare four different heart rate monitors (Apple Watch Nike III,Fitbit Iconic, Garmin Vivosmart HR, Tom Tom Spark 3) to an Electrocardiograph (ECG) machine to determine the accuracy of the devices. Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Elite athletes often use heart rate measurements to monitor training and fitness levels. In response, fitness companies have offered a variety of heart rate monitors to the general public. Previously, chest strap monitors that measured electrical activity were mainly used to track heart rates. More recently, wrist-worn monitors that use an optical sensor (light) to measure heart rate have gained in popularity. While the accuracy of chest strap monitors has been studied, there is currently no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important for subjects who rely upon the heart rate measurements to guide their athletic activity.

In 2018, worldwide sales of wearable fitness monitors are anticipated to exceed 110 million. Millions of consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment and awareness of the accuracy of heart rate measurements becomes increasingly important.

In previous trials, the investigators assessed the accuracy of 4 wrist-worn HR monitors (Apple Watch, Fitbit Blaze, Garmin Forerunner 235, TomTom Spark Cardio) in healthy adult volunteers during various types of exercise. The investigators discovered that the accuracy varied with exercise type. With the treadmill, all devices were acceptable (rc =.88-.93) except the Fitbit Blaze (rc=.76). While biking, the Garmin and Apple Watch were acceptable (rc \>.8). On the elliptical trainer without arm levers, only the Apple Watch provided accurate readings (rc=.94). None of the devices gave accurate readings for the elliptical trainer with arm levers (rc \<.8). That study is now published.

Reviewers of the investigator's previous work raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate in athletes performing at a high level of exertion? This study addresses that question.

The objective of this study is to evaluate the accuracy of four heart rate monitors in accomplished athletes (i.e. runners) performing at various levels of exertion, including a high level of exertion.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients are able to run a mile in 7 minutes or less

Exclusion Criteria:

* Presence of a cardiac pacemaker
* Known chronic and persistent heart rhythm disorders
* Tattoos around the wrist or forearm area
Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District

The goal of this observational study is to collect structured data about diagnosis, treatment and follow-up of rare and highly complex neoplasms.

The study has a rerospective part that will consist in gathering data on patients accessing IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola from 01/01/2000 to 28/09/2017 and a prospective one ranging from 29/09/2017 to 31/12/2025.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologic diagnosis of rare or highly complex malignant neoplasm
* informed consent

Exclusion Criteria:

* none
Factors Associated With Pain Level Experience in Orthodontic Treatment

Orthodontic pain has been the primary concern from all patients who requires orthodontic treatment. The design of the study will help us comprehend how patient experienced and managed pain during their orthodontic treatment, average pain level in different orthodontic appliances and factors that could affect pain level experience during treatment, including gender, age, brackets types, hygiene level and habitude.

To interpret the average pain level experience in orthodontic treatment and find correlations of different pain level within each individual from the clinical reports and questionnaires collected from each patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient with orthodontic treatment over 2 months and less than 12 months
* Patient with braces or Invisalign
* Patient who goes to orthodontic visits routinely

Exclusion Criteria:

* Patient undergoing orthopaedic treatment (Functional appliances, 2x4 braces placement, maxillary expansion)
* Patient who do not understand Spanish
* Patient with cognitive impairment
* Patient who do not want to participate in the study
* Patient who have complete their orthodontic treatment
Phenotypic Properties in Individuals Affected With XLHED

The current study design incorporates two previously developed, non-invasive approaches to characterize the phenotype of individuals affected with XLHED.

The current study design incorporates two previously developed, non-invasive approaches to characterize the phenotype of individuals affected with XLHED. Facial 3-dimensional (3D) imaging will be created from white-field morphometric scanning (Hammond, 2004. The 3D facial photographs collected from males (ages 4 years and up) will be used to develop a non-invasive screening tool, which could enable detection of craniofacial signs of XLHED in the newborn period. 3D facial profiling has been reported to be effective in identifying HED (Dellavia et al., 2008), but the technology does not yet meet the ease-of-use criteria for a universal screening tool.

Standard 2-dimensional (2D) frontal and lateral facial photographs will be taken of the same XLHED-affected male subjects as well as of adult females (ages 18-45 yrs) at risk for being XLHED carriers and unaffected adult female controls. The 2D facial photographs will serve a dual purpose; the first being to beta-test a previously developed algorithm to identify males affected with XLHED (Automatic Phenotype Identification of XLHED Patients Final Report, December 25, 2012, unpublished), and the second to adapt the facial recognition algorithm to identify female carriers of XLHED.

Eligibility Criteria:
Inclusion Criteria:

1. Females of original gender of age 18-45 years who are registered and attending the 2013 NFED Family Conference. This will include those at risk for XLHED and controls
2. XLHED-affected males of original gender of age 4 yrs and up who are registered and attending the 2013 NFED Family Conference
3. Provide informed consent/assent

Exclusion Criteria:

1. Subjects who are not able or are not willing to comply with the procedures of this protocol
2. Subjects with any major medical problem that will prevent them from participating in this study
3. Male subjects who participated in the prior study ECP-003 sponsored by Edimer Pharmaceuticals Inc. in May 2011 in San Francisco, CA
4. Males at risk for XLHED with prior genetic testing that did not reveal an EDA mutation
Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study

Hip and knee replacements are indicated to improve long-term quality of life and pain. These long-term results may depend on the quality of the initial postoperative recovery.

However, early postoperative health status after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is not accurately described. Through this retrospective study, the investigators wanted to describe the perioperative state of health monitored using the QoR-15 questionnaire for THA and TKA patients from the perioperative moment to postoperative day 28.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years)
* Having benefited from an ATG or ATH at Strasbourg University Hospital between March 1, 2020 and December 31, 2022
* Tracked with QoR-15 score
* Patient not opposing the reuse of his data for scientific research purposes

Exclusion Criteria:

* Refusal to participate in the study
* Patient admitted to THA for a hip fracture
* Patient admitted for multiple THA or TKA