cyrilzakka/clinical-trials huggingface dataset:
Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Osteopathic treatment will provide:

1. A significant reduction of pain and swelling of the affected DVT leg
2. An increase in the quality of life (QOL) for individuals with DVT of the leg
3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg

Thousands of individuals are affected by deep vein thrombosis (DVT) every year. Medical treatment is aimed at preventing extension and recurrence of the blood clot (DVT) through the use of anticoagulation medication. Compression stockings may be added for reduction of pain and swelling, but this therapy remains controversial amongst physicians. To date, there is limited manual therapies available for individuals affected with DVT. Regular medical treatment, anticoagulation medication, along with osteopathic treatment may offer these individuals improved control of the symptoms associated with DVT. In the long term osteopathic treatment may provide an increase in the quality of life (QOL) and improve the signs and symptoms associated with the post-thrombotic syndrome (PTS), which can be burdensome for both the individual and the health care system. Offering an effective add on treatment could provide individuals and the medical system with an additional means of treatment for the symptoms of DVT and also for the prevention of development of PTS.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* first episode of symptomatic objectively confirmed proximal leg DVT without pulmonary embolism
* 1 month of appropriate anticoagulation treatment
* therapeutic level of anticoagulation (ie: Warfarin, INR- 2.0-3.0)

Exclusion Criteria:

* \> 1 month + 7 days of anticoagulation
* history of previously confirmed proximal or distal leg DVT
* medically unstable individuals requiring hospitalization
* history of peripheral vascular disease (PVD)
* injury of affected leg (trauma within the last 6 months or leg currently casted)
* history of previous stroke
* uncontrolled hypertension
* renal failure requiring hemodialysis or peritoneal dialysis
* diagnosis of cancer in the last five years or currently receiving treatment for cancer
* open heart or vascular surgery in the last year
* any neurological condition (ie: MS, ALS, Parkinsons, etc)
* currently pregnant
* geographic inaccessibility
* unable to provide informed consent
Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate

The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.

All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surg ery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.

All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.

The latest follow up should be completed by 31.03.2022.

For both, the retro- and prospective arm, the time needed for the follow-up appointment is approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the questionnaires is estimated to take 20-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Initially suffering from ventral abdominal hernia
* Performance of open ventral abdominal hernia repair with self-adhering, atraumatic mesh (Adhesix ®)
* Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion Criteria:

* Inability to comply with the study protocol
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.


Eligibility Criteria:
Inclusion Criteria:

* Present with type 2 diabetes
* Patients have been treated with a stable dose of the following for at least 3 months prior to screening:

  * 100 mg/day sitagliptin and
  * ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
* Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
* Have a body mass index (BMI) ≥20 kg/m2 and \<45 kg/m2

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or withdrawn from this study or any other study investigating exenatide.
* Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
* Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
* Are currently treated with any of the following excluded medications:

  * Thiazolidinediones (TZD) within 3 months of screening.
  * Sulfonylurea (SU) within 3 months of screening.
  * Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, with the exception of sitagliptin, within 3 months of screening.
  * Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
  * Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
  * Exogenous insulin within the 3 months prior to screening.
  * Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
  * Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
  * Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.
Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect

The purpose of this study is to test the feasibility and acceptability of an evidence-based treatment for depression delivered over an ipad, computer, or smartphone can help Adult Protective Services (APS) clients with their activities of daily living to evaluate whether reductions on measures of depression and apathy (a) mediate reduced Elder Neglect/Self Neglect (EN/SN) behaviors; and (b) whether secondary posited mediating mechanisms are also active in impacting depression and apathy


Eligibility Criteria:
Inclusion Criteria:

* APS Case in APS Region VI- Must have open case
* PHQ 9 score- Must have score of nine (9) or more

Exclusion Criteria:

* Previous mental health diagnosis of bipolar disorder, psychotic disorders, and moderate to severe dementia
* Assessment of Consent Proxy- Those who need assessment of consent proxy
* Suicidal Intent (as indexed by PhQ-9 question 9)- Those scoring 2 or 3
* Current Alcohol and Drug Dependency- As evidenced by Cut down, Annoyed, Guilty, and Eye-opener (CAGE) score of 3 or more
Assessment of an Oral Endotracheal Subglottic Tube Holder

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

Eligibility Criteria:
INCLUSION CRITERIA

1. Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
2. Requires the use of a bite block per the hospital's standard of care
3. Has intact skin on and around application site, including cheeks and lips
4. Oral cavity is free of open sores, ulcers, wounds, and lesions
5. Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
6. Is qualified to participate in the opinion of the Investigator, or designee

EXCLUSION CRITERIA

1. Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
2. Has facial hair that interferes with the adhesion of the skin barrier pads
3. Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
4. Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
5. Has a known or stated allergy to adhesives
6. Currently is participating in any clinical study which may affect the performance of the device
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.

The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Patient with ptosis that requires correction
* Patient is able to consent for themselves

Exclusion Criteria:

* Patient unable to complete survey
* Patient had prior lid surgery
* Patient taking chronic pain medication
Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD)

The purpose of this study is to assess the safety, tolerance, pharmacokinetics, and pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male X-ALD patients.

Subjects will have a screening visit within 6 weeks prior to the Baseline visit. At Baseline visit blood will be drawn and to establish baseline values for plasma and red blood cell (RBC) very long chain fatty acids (VLCFA; C22, C24, and C26). Subjects will receive an oral dose of 50 mcg sobetirome once daily for 14 days beginning on Day 1. Subjects will be kept in the clinic on Day 1 for 16 hours following their initial dose of sobetirome for repeat blood sampling for pharmacokinetic analysis. Subjects will return to the clinic on days 7, 15, 21 and 28 for blood collection for VLCFA measurements. On day 15, after safety assessment, subjects will receive an increased dose of 100 mcg and this dose will be continued once daily through Day 28. Subjects will continue to return to the clinic weekly for blood and urine collection and safety assessments. Subjects will return to the clinic on day 42 for an End of Study visit that will involve a final measurement of VLCFA and blood and urine safety labs to check for reversibility. Safety labs will include serum chemistry, free fatty acid profile, hematology, urinalysis, and thyroid function. Subjects will be monitored with ECGs, vital signs, physical exams and assessment of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* males 18-65 years old
* X-ALD diagnosis by either elevated VLCFAs or DNA testing
* must sign informed consent and agree to complete required clinic visits.

Exclusion Criteria:

* female gender
* abnormal laboratory test results (except VLCFA) at screening visit
* history of coronary artery disease
* use of triiodothyronine therapy
* abnormal thyroid function test at screening visit
* untreated adrenal insufficiency
* currently taking Lorenzo's Oil or other VLCFA lowering agent
* participation in investigational drug study within 30 days
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease

COVID-19 caused by SARS-CoV-2 virus has affected the lives of millions of individuals globally and also severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greater than earlier viral outbreaks of SARS-CoV and MERS-CoV.Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is sparingly explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. Meta-analysis of five clinical trials of vitamin D supplementation found that those receiving vitamin D supplementation had fewer respiratory tract infections (odds ratio = 0.58 (95%CI, 0.42 - 0.81).Any immune-modulatory effect of vitamin D is likely to be observed at levels which are considered higher than that required for normal bone metabolism.


Eligibility Criteria:
Inclusion Criteria:

1. RT-PCR proven SARS-CoV-2 infection or computed tomography scan findings compatible with the COVID19 disease (bilateral multifocal ground-glass opacities ≥50%)
2. Moderate to severe COVID-19 defined by PFR ratio of \<200
3. SOFA score\>4
4. Patients with vitamin D deficiency defined as 25 (OH)D level\<20 ng/ml
5. Age\>18 years

Exclusion Criteria:

* 1. Vitamin D sufficient or already receiving vitamin D supplements 2. Active malignancy 3. Hypercalcemia, hyperparathyroidism 4. Chronic kidney disease (eGFR\<30 ml/min) 5. Pregnant and lactating women 6. Patient on mechanical ventilation at ICU admission
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline

The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force (USPSTF) and American Academy of Pediatrics (AAP) guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations

Eligibility Criteria:
Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria:

Inclusion criteria

* Age 6-17.9 years at time of screening
* BMI ≥ 85th percentile
* Asthma diagnosis, per child's Electronic Health Record (EHR) documentation or caregiver report

Exclusion criteria

* Diagnosis of anorexia nervosa, per child's EHR or caregiver report
* Pregnant, per child's EHR
* Plan to change pediatricians in the next year, per caregiver report
* Opted out of research, per child's EHR
* Sibling currently enrolled in the research trial, per enrollment log or caregiver report
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).


Eligibility Criteria:
Inclusion Criteria:

* Patients should complete the 24 month core study

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.
Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression

Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Background: Sleep problems, pain, and depression are common health issues in individuals with fibromyalgia. However, studies on sleep hygiene education to address these problems are limited in the literature.

Methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for the study were as follows:

* Being 18 years of age or older,
* Having a diagnosis of Fibromyalgia (FM) for at least 3 months,
* Being reachable,
* Agreeing to participate in the study,
* Not receiving treatment for depression,
* Not having received similar education on sleep hygiene,
* Having a VAS pain score \>3,
* Having a PSQI score \>5.

Exclusion Criteria:

Additionally, the exclusion criteria for the study were as follows:

* Having a diagnosis of FM for less than 3 months,
* Using sleep medication,
* Having chronic illnesses that could interfere with sleep such as Chronic Obstructive Pulmonary Disease (COPD) or asthma,
* Working on night shifts.
Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to the QuitGuide app in helping cancer patients quit smoking. Both apps provide tools to cope with urges to smoke, step-by-step guides for quitting smoking, help in planning for quitting and staying tobacco-free, and scientifically-based recommendations for how to select medications that aid in smoking cessation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

ARM II: Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

After randomization, patients are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with cancer within the past 24 months or currently receiving or planning to receive cancer treatment in the next 3 months
* Smoked a cigarette (even a puff) in the past 30 days
* Interested in learning skills to quit smoking
* Willing to be randomly assigned to either smartphone application
* Live in the United States and will remain in the United States (US) for the next 12 months
* Have at least daily access to their own smartphone
* Know how to download a smartphone application
* Be willing and able to read English
* Not currently (i.e., within past 30 days) using other smoking cessation interventions
* Have never participated in our prior research trials
* Have never used the National Cancer Institute (NCI)'s QuitGuide app
* Being willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
* Providing email, phone number(s), and mailing address

Exclusion Criteria:

* Currently (i.e., within past 30 days) using other smoking cessation interventions
* Has participated in our prior research trials
* Has used the NCI's QuitGuide app
* Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
* Not providing email, phone number(s), and mailing address