cyrilzakka/clinical-trials huggingface dataset:
Comorbidity Screening and Referral by Prosthetists

Lower-limb amputation is associated with life-altering and life-limiting comorbidities. Currently, onus is on primary care providers to diagnose, educate, and refer patients for appropriate management. Recently our laboratory has found, however, that of adults post-amputation seen in an outpatient Limb Loss Clinic presenting with comorbidities, \>50% are unaware they have signs of peripheral arterial disease and/or neuropathy. Lack of patient awareness and thus, inadequate comorbidity management, may contribute to suboptimal patient outcomes post-amputation. As a first step in this research line, the proposed project will help determine if comorbidity screening by prosthetists during routine care visits for patients post-amputation may enhance comorbidity awareness, increase patient satisfaction in prosthetic services, and reduce gratuitous prosthetic service utilization. During a follow-up visit, seventy patients following a unilateral lower-limb amputation will be randomized into either a standard-of-care group or a standard of-care plus group. The standard-of-care plus group will receive clinical screenings by a certified prosthetist for peripheral arterial disease, peripheral neuropathy, depression, and high-risk for persistent back pain; patient education on findings; and each participant's primary care provider will receive screening results. The long-term goal of this research is to determine if prosthetists can maximize their utility in an interdisciplinary care team, while enhancing patient outcomes post-amputation.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking and -reading
* Unilateral transtibial (i.e., below-knee) or transfemoral (i.e., above-knee) amputation
* Utilization of a prosthesis for at least 1 year
* Willingness to have screening results communicated to their primary care provider
* Receiving prosthetic care at Independence Prosthetics-Orthotics, Inc.

Exclusion Criteria:

* Cognitive impairment precluding ability to consent to study participation
* Contralateral limb amputation greater than toe-level
* Severe vision or hearing loss
* Receipt of a replacement prosthetic component within the 3 months prior to study enrollment
* Hospitalization within the 3 months prior to study enrollment
Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients

EGFR gene mutations are some of the most commonly occurring mutations in non-small cell lung cancer. Investigators have developed a DNA instability model that estimates a risk score to assess the likelihood of an individual acquiring a cancer-linked mutation. The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* Biologically born female
* Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)
* No cancer diagnosis (Arm 2-health control)

Exclusion Criteria:

* less than 18 years of age
* Biologically born male
* Incarcerated at the time of participation
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.

Patients with a diagnosis of ACL tear or hip pathology will undergo surgery. Following surgery, patients will report to clinic for scheduled physical therapy per their institution's injury-specific physical therapy protocol. At set time points (6-week, 12-week, 6 months, and 9 months) during their recovery, patients will be assessed for muscle oxygen saturation and hemoglobin levels with the Moxy sensor. This sensor is a non-invasive device placed over the rectus femoris to monitor oxygen and hemoglobin levels. The patient will then follow the therapy as instructed by the physical therapist and perform the protocol-specific exercises with the sensor in place. The measured parameters will be recorded and stored per patient.

The injured patients will be compared to healthy control patients undergoing a similar one-hour exercise session while wearing the Moxy sensor for comparison of results.

The goal of this study is to use the data obtained from the Moxy sensor device to further predict recovery of function in muscles supporting injured soft tissues to determine safe return to sport.

Eligibility Criteria:
Inclusion Criteria:

* Age range: Patients age 14 to 30 years
* Patients with ACL injury requiring surgical correction
* Patients undergoing arthroscopic hip surgery
* Healthy individuals with no history of ACL, arthroscopic knee or arthroscopic hip surgery

Exclusion Criteria:

* Patients below 14 years or above 30 years
* Non-English-speaking subjects
* Pregnant individuals
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1

The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas


Eligibility Criteria:
Inclusion Criteria:

* Those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration \& transplantation or intrauterine device(IUD), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide \& male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum.
* Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial

Exclusion Criteria:

* In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
* Those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug from 48 hours before the first administration date to post study visit(PSV)
* Those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (However, if necessary, such as treatment of adverse event, it can be administrated according to investigator's judgment)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 4 weeks before the first administration date (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study
Yoga Exercises Applied With Two Different Technological Access

Yoga, a form of exercise designed to bring balance and health to the physical, mental, emotional and spiritual dimensions of the individual, will benefit many white-collar workers by using popular technological environments to increase overall physical activity and well-being. The aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency.

Considering the importance of the workforce and possible health problems in white-collar workers, it seems rational to implement health promotion practices in accordance with the digital age. There is no study in the literature examining the effectiveness of technology-based yoga on selected health outcomes in white-collar workers. Based on this shortcoming, the aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency.

Eligibility Criteria:
Inclusion Criteria:

* • Working full-time in the last 1 year in administrative, research-development, high-tech education, mind and brain power-based jobs

  * Speaks and writes Turkish
  * In order to join online sessions, participants should have internet access
  * All answers of the Physical Activity Preparation Survey should be selected as "No"

Exclusion Criteria:

* • Uncontrolled hypertension and uncontrolled arrhythmia patience

  * Individuals who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker
  * Individuals with severe neurological disease or serious respiratory disease
  * Previous stroke, myocardial infarction
  * Individuals who have undergone amputation
  * Individuals with major musculoskeletal problems
  * Individuals with injuries involving the lower extremity in the past 6 months
  * Pregnant or planning a pregnancy within 1 year
  * Breastfeeding
  * Use of sleeping pills or medication for psychological problems and/or shift workers
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR

To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).


Eligibility Criteria:
Inclusion Criteria:

* Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal

Exclusion Criteria:

* any sign of retinal redetachment before silicone oil removal
* any sign of diabetic retinopathy
Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)

This research study wants to learn more about Duchenne Muscular Dystrophy (DMD) and exercise. Today it is unknown how exercising impacts boys with DMD. The investigators believe that increasing activity and aerobic exercise may help with heart, lung, and muscle function. The investigators are hoping to compare physical strength and blood samples of boys with DMD to see if there are any differences between kids who exercised more as a child versus those who didn't.

Recently, the American Academy of Neurology released new guidelines for children with Duchenne Muscular Dystrophy (DMD) with an updated recommendation to include moderate aerobic exercise. Historically, children with DMD were advised to not exercise as it was thought to accelerate muscle loss. Today, there is new data suggesting that moderate aerobic exercise that does not strain muscle may be beneficial and improve a child's quality of life with regard to heart disease, fatigue, and other factors of overall health. Although it is expected that children who exercise will experience health benefits, there is no scientific evidence indicating a positive or negative effect in a DMD population.

This study is trying to understand the role of aerobic exercise in boys with DMD and how it may impact heart, muscle, and lung function using newly identified biomarkers. The goal is to correlate increased aerobic exercise with improved functional outcomes and changes in biomarkers.

The data collected from this study will allow future development and implementation of an innovative and disease-specific home aerobic exercise program that in the future will be recommended to families of children with DMD.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2-17 years old with a confirmed diagnosis of DMD. Has an appointment in MDA clinic at the Ann \& Robert H. Lurie Children's Hospital of Chicago.

Exclusion Criteria:

* Is less than two years old and does not have a confirmed diagnosis of DMD.
Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Postdural puncture headaches (PDPH) are a common consequence of diagnostic lumbar puncture. The gold standard treatment for a PDPH is currently an autologous epidural blood patch (AEBP), which involves placing a needle into the epidural space of the spine and then injecting 20 ml of the patients own blood through the needle and into the epidural space to form a clot over the tear in the tissue layer that causes the headache. This is an invasive procedure that carries risks of pain, bleeding, infection, and in rare cases, neurological complications. We want to test the efficacy of using a less invasive procedure, called a sphenopalatine ganglion block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. We hope that the SPGB will reduce the number of PDPH patients that require an AEBP.

Eligibility Criteria:
Inclusion Criteria:

* Active postdural puncture headache within 7 days after diagnostic lumbar puncture
* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria:

* Known coagulopathy
* Known nasal septal deviation or abnormalities
* Medical conditions contraindicated to lidocaine or bupivacaine
Action Seniors! Exercise to Prevent Falls

This study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls.

A total of 344 community-dwelling adults aged 70 years and older who are referred to a falls clinic secondary to seeking medical attention due to a fall will be randomized to either the 12-month OEP group or usual care. There will be three measurement sessions: baseline, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adults older than or 70 years attending a Falls Prevention Clinic Service;
2. Understands, speaks, and reads English proficiently;
3. MMSE 8 score \> 24/30;
4. Had one documented non-syncopal fall in the last 12 months and one of the following: a) A Physiological Profile Assessment (PPA) score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) performance of greater than 15 seconds; OR 3) One additional documented non-syncopal fall in the previous 12 months;
5. Expected to live greater than 12 months;
6. Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
7. Able to walk 3 meters with or without an assistive device; and
8. Able to provide written informed consent.

Exclusion Criteria:

1. Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
2. Diagnosed with dementia (of any type);
3. Had a stroke;
4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
5. Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Concentrations of Formoterol in Blood and Urine

The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.

The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose.

Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18-45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to study day.
* Subjects with other chronic diseases than asthma and allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 10 days prior to study day.
Interval Training Study in Psoriatic Arthritis

Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index.

A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training.

The primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. This intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* fulfilling the CASPAR criteria of psoriatic arthritis
* ability to exercise.

Exclusion Criteria:

* Inability to exercise
* very high disease Activity
* unstable ischemic cardiovascular disease
* severe pulmonary disease
* pregnancy
* breastfeeding
* drug- and alcohol addictions
Dose-to-block Level Relation in Single Shot Spinal Anesthesia for Cesarean Section.

The study is designed to support or deny relation between the dose of hyperbaric bupivacaine given intrathecally and extent of spinal block level. There is ongoing debate whether anesthetists should adjust the dose in the range of conventional doses in order to achieve appropriate coverage of anesthesia which would be suitable for cesarean section.

Two strategies are predominantly used: low dose strategy, which is focused on safety, and conventional dose approach, which is more effective in terms of success of anesthesia, with markedly higher rate of spinal block - related complications. It is hypothesized that there may be no relation between block level and the dose if conventional doses are used. For that purpose anesthetic charts of cesarean sections will be reviewed to gather information on the doses of anesthetic used and the level of spinal block they produced.

Single - shot spinal block for cesarean delivery is a gold standard in obstetric anesthesia. Both level and density of the block may have direct impact on the quality of surgery, patient's comfort and the course of postoperative recovery. Ideal dose of local anaesthetic for single - shot spinal anesthesia is still to be decided, with ongoing debate on using either "low" or "conventional" doses as routine approach. Use of conventional doses of local anesthetic (doses nearing dose effective in 95 percent of patients,ED95) have proven to be superior to low dose regimens in terms of effectiveness and therefore this strategy is widely used, despite the higher risk of spinal block - related complications.

Amount of local anesthestic used is regarded to be a factor of significant influence on its intrathecal spread and the final level of block following single - shot spinal anesthesia. It was investigated in both general and obstetric populations, although most of the studies with results in favor of this relation were designed to assess the other factors, and the extend of sensory block was not set as their primary outcome.

It was previously reported that adjusting the conventional dose of hyperbaric bupivacaine to parturient's height does not change the risk of block failure and rate of complications when compared to fixed - dose regimen. Whether the change in bupivacaine dose within the range of conventional doses results in significant change in sensory block level is not clear.

This retrospective analysis was designed to assess the above relation

Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery at term under spinal anesthesia
* American Society of Anesthesiologists (ASA) physical status \<3
* BMI\<40

Exclusion Criteria:

* Spinal anesthesia with less than 9mg of hyperbaric bupivacaine
* Local anesthetic other than hyperbaric bupivacaine used
* Failed spinal anesthesia
* Poor quality of the anesthetic record - data required for analysis not available
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has been reported to be effective in the acute attack of shoulder tendonitis, however, has never been examined in controlled study in patients with chronic shoulder pain secondary to calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration) due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or placebo (lactose capsules) for 4 months. At the end of this blinded part of the study, patients who received placebo and did not improve, will be eligible to continue study in the open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups will be scheduled bi-monthly for all patients.


Eligibility Criteria:
Inclusion Criteria:

* chronic, more than 3 months duration, shoulder pain
* tendinous calcifications on shoulder X-rays

Exclusion Criteria:

* renal insufficiency
* liver insufficiency
* lactose intolerance
* hypersensitivity to colchicine
Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity

This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI between 25 and 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction