cyrilzakka/clinical-trials huggingface dataset:
Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet

Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (RA) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with RA and determine the correlation between ultrasound and radiography in the detection of bone erosion.

Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal \[MTP\] joints) of 50 healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.


Eligibility Criteria:
Inclusion Criteria:

Rheumatoid Arthritis Group:

* RA with at least one year since diagnosis
* Asymptomatic feet
* Age between 18 and 65 years Control group
* absence of known osteoarticular disease

Exclusion Criteria for both groups:

* Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis
* Previous surgical intervention and/or fracture in feet/ankles
* Intra-articular corticosteroid injection in previous three months in any of the joints evaluated
* Foot neuropathy
* Pain and swelling in feet or ankles
The Effects of One-Time Pregnenolone, Dehydroepiandrosterone (DHEA), or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include assessing whether these agents relieve craving for cigarettes elicited by exposure to a mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and placebo will be administered one at each of the three sessions in a randomized order.


Eligibility Criteria:
Inclusion Criteria:

1. male;
2. 18-65 years old;
3. smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine;
4. afternoon expired carbon monoxide reading of at least 10 ppm;
5. in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.

Exclusion Criteria:

1. Participants must not have uncontrolled hypertension (systolic \>140 mm Hg, diastolic \>95 mm Hg)
2. hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg);
3. coronary heart disease;
4. heart attack;
5. cardiac rhythm disorder (irregular heart rhythm);
6. chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source);
7. cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
8. liver or kidney disorder (except kidney stones, gallstones);
9. gastrointestinal problems or disease other than gastroesophageal reflux,
10. heartburn, or irritable bowel syndrome;
11. ulcers within the past 6 months;
12. lung disorder (including but not limited to COPD, emphysema, and asthma);
13. brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder);
14. history of fainting;
15. problems giving blood samples;
16. diabetes;
17. current cancer or treatment for cancer in the past 6 months (except basal or squamous cell skin cancer);
18. other major medical condition;
19. major depression, panic disorder, anxiety, bipolar disorder, schizophrenia, risk of suicide, or substance dependence other than nicotine dependence;
20. subjects who endorse suicidal ideation on the MINI abridged;
21. alcohol or drugs abuse;
22. reported use of illicit drugs within the past 30 days, or if the drug screen is positive;
23. reported use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, or nicotine replacement therapy; testosterone replacement therapy, DHEA or Pregnenolone; experimental (investigational) drugs; psychiatric medications (including antidepressants, anti-anxiety agents. anti-psychotics), sleep aids, medications that increase DHEA and/or DHEA-S concentrations (including, but not limited to: diltiazem, benfluorex, amlodipine, alprazolam, danazol, metformin, nitrendipine and retinol), or any other medications that are known to affect smoking (e.g. clonidine, muscle relaxants, opiate pain medications) within the past 2 weeks.
Muscle Pressure Estimation With Artificial Intelligence During Mechanical Ventilation

The goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. The main questions it aims to answer are:

• Are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon?

Participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.

This is a diagnostic study to validate estimation of inspiratory muscle pressure during assisted ventilation from an artificial intelligence algorithm integrated in a mechanical ventilator (FlexiMag, Magnamed, Brazil) compared to direct measure of muscle pressure from esophageal catheter balloon (gold standard). This is a novel non-invasive method to estimate inspiratory muscle pressure.

After obtaining informed consent, participants will be monitored simultaneously with the esophageal balloon and the artificial intelligence algorithm, with decremental levels of pressure support (20 to 2 cmH2O, in steps of 20 minutes). Esophageal balloon will be removed after completing the last pressure support step.

The investigators estimated a sample of 50 participants, considering 3 cmH2O as a clinically relevant discordance between methods and 10% of missing data. Concordance analysis and correlation analysis will be performed.

Procedures will follow a specific Standard Operating Procedures and participants inclusion data will be inserted in REDCap.

Eligibility Criteria:
Inclusion Criteria:

* Patients under assisted or assist-control mechanical ventilation

Exclusion Criteria:

* Contraindication to esophageal catheter insertion (esophageal cancer or bleeding, esophageal fistula, skull base fracture, uncontrolled coagulopathies)
* Contraindication to transient neuromuscular blockade
* Bronchopleural fistula (persistent air leak)
* Hemodynamic instability (norepinephrine \> 1mcg/kg/min)
* Gestation
* Current sinus infection
* Refusal from patient's family of attending physician
* Palliative care
Clinical Cohort Study - TRUST

The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.

Arrhythmias such as atrial fibrillation, ventricular tachycardia, and sudden death remain major causes of morbidity and mortality. Their prevalence increases in our ageing populations. Modern therapy of these conditions, using a combination of drugs, devices, and interventions, can reduce the disease burden associated with cardiac arrhythmias. This prospective cohort study will collect detailed clinical, procedural, and outcome information in a large cohort of patients with arrhythmias seen in a tertiary care center. Clinical phenotyping will be enhanced by biosampling and analysis of circulating biomolecules. Digital capture of clinical information and of follow-up data is planned.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baseline or high risk for cardiac arrhythmia
* Age ≥ 18 years
* Written informed consent
* Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Insufficient knowledge of the German language to understand study documents and interview without translation
* Physical or psychological incapability to cooperate in the investigation
Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I

The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.

Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up

Eligibility Criteria:
Inclusion Criteria:

* chronic patellar tendinopathy (\> 3 months)
* anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
* hypo-echoic area with enhanced vascularization

Exclusion Criteria: injection

* corticosteroid injection within the last 12 months
* Knee operation
* Knee osteoarthritis
* Diabetes
* Smoking
* Body mass index \>30
Study of Lactobacillus in Adjuvant Treatment of RVVC

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

vulvovaginal candidiasis is common disease in women. Its refractory and high recurrence rate has always been a clinical problem. Some cases even recur several times a year, and those who recur more than four times a year are diagnosed as recurrent vaginal candidal infection Candidiasis, RVVC）。 The common clinical regimen for VVC is to strengthen and consolidate clotrimazole vaginal tablets for up to 25 weeks. However, long-term antibiotic treatment will lead to the decrease of vaginal microflora and the disappearance of inflammation and pathogenic bacteria, which will greatly increase the probability of repeated infection and become a barrier to clinical treatment. If probiotics are added in the treatment, the abundance of lactobacillus can be ensured while antibiotic treatment is carried out, the homeostasis of reproductive tract flora can be reestablished, the defense mechanism can be improved fundamentally, and the re invasion of pathogenic bacteria can be reduced, which will become a new treatment idea and method for radical cure of refractory RVVC.

We hypothesize that Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis.

Eligibility Criteria:
Inclusion Criteria:

* Women be at least 18 years of age
* Have symptoms of vulva irritation and or abnormal discharge
* Meet the clinical criteria for RVVC
* Willing to participate in research

Exclusion Criteria:

1. Taking / injecting antibiotics in the past two weeks;
2. A woman who intends to be pregnant, pregnant or lactating;
3. Long term use of contraceptives and immunosuppressants;
4. Postmenopausal;
5. There was no same fixed sexual partner (RSP) before and after treatment
6. Patients with severe gastrointestinal diseases, including colorectal cancer, IBS, IBD, chronic or acute diarrhea, long-term constipation, etc., or receiving gastrointestinal surgery and abdominal surgery within one year, such as cholecystectomy;
7. Patients with severe heart, liver and kidney dysfunction, mental diseases, infectious diseases, tumors, severe anemia, and severe autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, etc.)
The Effect of Acupressure on Menopausal Symptoms

This is a prospective, randomized, placebo-controlled and single-blind study planned to determine the effect of acupressure application on menopausal symptoms.

The hypothesis of the study is that acupressure reduces women's menopausal symptoms.

Menopause is a physiological process during which most women have difficulties and face many problems. Acupressure can be taught and used safely as an effective method to manage the symptoms that women experience during menopause.

This study aims to determine the effect of acupressure on menopausal symptoms. The study has a prospective, randomized, sham-controlled, single-blind design. The research was conducted with 81 women (acupressure n=40, sham acupressure n=41) attending the "Menopause School" in a public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received acupressure application thrice a week for four weeks, 12 sessions in total. The data was obtained using a personal information form and a Menopause Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and understand Turkish
* No psychiatric illness
* Natural menopause
* Not on hormone replacement therapy
* Women who volunteered to participate in the study and did not receive any integrated therapy were included.

Exclusion Criteria:

* Those who have undergone menopause with the surgical method
* For lower extremity vascular disease, fracture, sprain or injury, diabetes, cardiovascular disease, thyroid disease, etc. with a diagnosis
* Women who received any integrative therapy were not included in the study.
Individual Patient Compassionate Use of Fedratinib

This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib.

Expanded access is only available in markets where fedratinib is not yet approved.

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.

Exclusion Criteria:

Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).

The focus of this study is Aim 1.

Eligibility Criteria:
Inclusion criteria:

* age 18-60,
* be able to provide written informed consent,
* meet criteria for BPD on semi-structured clinical interview,
* able to plan to keep any prescribed medications and psychotherapy constant during the study
* fluent in English.

Exclusion criteria:

* current DBT psychotherapy outside the study
* lifetime primary psychotic disorder or Bipolar I disorder
* developmental disorder (e.g. autism)
* history of learning disorder
* moderate or severe substance use disorder in the last 6 months
* active suicidal ideation with intent or plan in the past 3 months
* history of major medical or neurologic disorder
* MRI contraindications, including pregnancy
* poor performance on reading task (WRAT \> 11 errors)
* newly prescribed medications in the past 8 weeks
* daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics)
* any scheduled daily benzodiazepines
* change in psychotherapy type or frequency in the past 12 weeks.
* At the discretion of the study PI

Eligibility will be determined by study personnel.
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.


Eligibility Criteria:
Inclusion Criteria:

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

* Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
* Total stool fat \> 40 g over 4 days (using Van De Kamer method)
* Proven chronic pancreatitis
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

* Ileus or acute abdomen
* Any type of malignancy involving the digestive tract in the last 5 years
* Presence of pseudo-pancreatic cyst ≥ 4
* Continued excessive intake of alcohol or drug abuse
* Known infection with HIV
Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry

The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naïve to P2Y12 inhibitors. These recommendations are based on the large Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) program, which encompassed three randomized controlled trials (RCTs) enrolling both chronic and acute coronary syndromes. Consistently, the aforementioned studies showed the benefit of cangrelor in terms of ischemic events (mainly driven by a reduction of myocardial infarction - MI - and stent thrombosis - ST) in the face of an increased rate of minor bleeding. However, those RCTs were primarily focused on populations at considerable ischemic risk and with predictably low bleeding proneness, including young patients without bleeding risk features.

In the contemporary practice, however, PCI is increasingly frequent in patients at high risk of bleeding, who are not formally prevented from being administered with cangrelor by international guidelines and possibly necessitate powerful and rapid-onset platelet inhibition while undergoing complex percutaneous revascularization. The present registry was therefore conceived at the scope of collecting data on the use of cangrelor in high bleeding risk (HBR) patients undergoing contemporary PCI. Specifically, it will assess the frequency of HBR patients in a real-world cohort of individuals treated with cangrelor and will compare the clinical outcomes of HBR and non-HBR patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes

Exclusion Criteria:

1. Cangrelor administration as a bridge to surgery
Optimizing Navigation to Successful Colorectal Cancer Screening

Colorectal cancer is the second leading cause of death from cancer in the United States. Two major barriers to successful colorectal cancer screening are appointment keeping and proper bowel preparation. The purpose of this study is to test the efficacy of a patient navigation program to increase colorectal cancer screening at Rush University Medical Center. The investigators hypothesize that colorectal cancer screening will be improved for subjects who utilize a patient navigator.


Eligibility Criteria:
Inclusion Criteria:

* Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary care physician
* Age 50 or greater or 40 or greater with family history of colorectal cancer in first degree relative
* Average risk for screening as defined as absence of symptomatic abdominal pain and active GI bleeding

Exclusion Criteria:

* Age \> 75 years old
* Congestive Heart Failure
* Chronic Obstructive Pulmonary Disease
* Myocardial Infarction
* Weight greater than 350 pounds
* Anticoagulation
* Inability to speak English
Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.

Evaluation results will be based in the following:

* Wrinkle severity score assessed using the Lemperle Wrinkle Scale
* Subject Satisfaction Scale
* PI Global Aesthetic Improvement Scale

Eligibility Criteria:
Inclusion Criteria:

* Males and females 40-70 years of age
* Fitzpatrick Skin Type I to IV as judged by the Investigator.
* Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
* Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits

Exclusion Criteria:

* Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
* History of keloid formation or hypertrophic scarring
* History of trauma or surgery to the treatment areas in the past 6 months
* Scar present in the areas to be treated
* Silicone injections in the areas to be treated
* Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
* Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
* Active, chronic, or recurrent infection
* History of compromised immune system or currently being treated with immunosuppressive agents
* History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
* Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
* Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
* History or presence of any clinically significant bleeding disorder
* Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
* Treatment with an investigational device or agent within 30 days before treatment or during the study period
* Female and pregnant or plan on becoming pregnant during the study