cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
* Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
* Participants prescribed upadacitinib in accordance with the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing to continue with study documentation after cessation of upadacitinib.
* Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).

Exclusion Criteria:

* Participants with any contraindication to upadacitinib.
* Participants previously exposed to upadacitinib in a clinical trial.
* Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).
Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence

Through a prospective RCT evaluate and compare the three new endovenous methods for great saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome) factors will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Clinical examinations by an experienced surgeon as well as duplex evaluation. Duplex evaluation of both the deep and the superficial system is required but not of the perforating vessels. It is performed by experienced BMA or surgeon with profound knowledge in vein diagnosis with duplex.
* Patients with primary varicose vein disease between age 18 to 75.
* Signature of informed consent.
* Varicose veins and duplex verified GSV incompetence defined as \>0,5 seconds reflux time after manual compression in upright position 60 degrees.
* Vein size \<20 mm in upright position 60 degrees, 2 cm below the SFJ.
* Minimum distance between skin and the GSV in the first 20 cm from the SFJ \> 5mm.
* CEAP classification C2-C5
* BMI \<35

Exclusion Criteria:

* Non-consent for randomisation.
* Age \<18 years.
* Age \>75 years.
* Deep vein insufficiency in the same extremity (duplex verified).
* Vein size \>20mm in upright position 60 degrees below the SFJ.
* Meander and superficial veins with a distance of \<5mm to the skin surface ( RF or Laser cannot be applied).
* Patients with double GSV's and/or lateral accessory insufficient branch.
* Patients with cognitive disturbances, dementia or unable to understand for any reason the importance of follow up.
* Earlier operation with HL/S (recurrency).
* Operated for small saphenous vein (SSV) incompetence the last 3 months.
* Known ABI \<0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
* Patients with recent cancer diagnosis or undergoing cancer treatment.
* BMI \>35.
* Patients with other known medical condition that contradict any of the treatments in the study.
* Minimum distance between skin and the GSV in the first 20 cm from the SFJ \>5mm.
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.

This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Kellgren Lawrence radiographic grade IV
2. Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
3. Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.
4. Males or females aged 45-75.

Exclusion Criteria:

-
Soft Drinks and Osteoporosis in WHI Participants

Osteoporotic fractures, as a consequence of a reduced mineral bone density (BMD) represents a major public health problem. The lifetime risk of fractures exceeds 40% for women and 13% for men. At least ten different individual characteristics have already been proposed, evaluated, and some of them accepted as risk factors. Some of those risk factors were compiled in a tool developed by the World Health Organization in order to predict the ten-risk for a new fracture, even without considering BMD in that prediction . Increased consumption of carbonated soft drinks has been reported to have associations to a lower bone mineral density and an increment in bone fractures among young and also elder subjects.

However, some prospective studies have not found any significant associations and others suggested that risk is only increased for some kinds of beverages, like cola beverages, but not to the entire universe of soft drinks. In this sense, a large prospective analysis performed on 1413 women and 1125 men from the Framingham Offspring Cohort, analyzed- the relation between soft drinks consumption and BMD at the spine and 3 hip sites. Cola intake was associated with significantly lower BMD at each hip site, but not the spine, in women but not in men. Similar results were observed for diet cola and, although weaker, for decaffeinated cola. No significant relations between non-cola carbonated beverage consumption and BMD were observed.

In spite of the fact that reduced bone mineral density and osteoporotic fractures represent an increasing burden of disease and disability in postmenopausal women, most of the studies performed in this population used BMD as primary outcome, and not common osteoporotic fractures (e.g. hip, spine or wrist). Therefore, there is no conclusive evidence of a potential causal association between soft drinks (cola and non-cola) and fractures in a population in which osteoporotic fractures hold the highest incidence.

This research proposal is based on using the Women Health Initiative data to analyze the relation between cola and non-cola soft drinks consumption on common osteoporotic fractures. BMD will be considered a secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* More than one day of follow up
* Dietary information on soft drinks

Exclusion Criteria:

Previous hip fracture
Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males

Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent inability to obtain and/or maintain a penile erection that is hard enough for satisfactory sexual intercourse. The number of reported patients with ED is increasing and it is becoming a real medical problem.

Marital satisfaction is a global evaluation of the state of one's marriage or current long-term romantic relationship. This global evaluation can be a reflection of a how happy people are in their marriage in general or a composite of satisfaction with several specific facets of the marital relationship. Sexual health can be described as enjoying and fulfilling sexual desires without harming, physical or psychological, oneself or others. Sexual functioning is an important part of a patient's health and well-being. Patients often seek for treatment late due to embarrassment and commonly with an alternative problem. Sexual and erectile functions are considered important components of men's overall health. The psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and marital difficulties. Personality is defined as the "distinctive and characteristic patterns of thought, emotion and behavior that define an individual's personal style and influence his or her interaction with the environment".

Eligibility Criteria:
Inclusion Criteria:

* Married couples

Exclusion Criteria:

* Unmarried couples.
Influence of Endurance Exercise and Histamine Receptors on the Gene Expression in Skeletal Muscle

Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses a twofold research question: "What is the influence of endurance training (1) and histamine H1 and H2 signaling (2) on the gene expression in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* 18-45 years
* not to medium physically active

Exclusion Criteria:

* Smoking
* Chronic disease
* Supplement or medication intake
* Seasonal allergies
Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block

Aim of the study is to determine the best cut off value for the PI and PI ratio for predication of successful supraclavicular brachial plexus block in young and middle age patients undergoing hand surgeries .

* The supraclavicular nerve block was performed under guidance of a linear transducer (8-14 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea) over the supraclavicular fossa in the coronal oblique plane immediately superior to the midclavicular point. The block was induced in the semi-sitting position, with the head of the patient turned away from the side to be blocked.
* The PI was measured using Masimo SET pulse oximeter, applied on the index finger. The PI was recorded at baseline and at 10, 20, and 30min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters.
* The PI ratio was calculated as the ratio between the PI at 10min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb was performed.
* PI was recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
* PI ratio was calculated as the ratio between the PI at 10 min after injection and the baseline PI.
* Vital data (Blood pressure, Heart rate, SPO2) was recorded before giving the block and at 10, 20, and 30 min after local anaesthetic injection and at the end of the operation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aging between 15_ 60 years of both sexes.
* Patients undergoing Elective hand Surgeries under successful supraclavicular brachial plexus block anesthesia.
* American Society of Anesthesiologists (ASA) physical status classes I - II.

Exclusion Criteria:

* Patient's refusal of procedure or participation in the study.
* ASA classes III or above.
* Coagulopathy and bleeding disorders.
* Contraindications to supraclavicular brachial plexus block anesthesia such as local infection.
* Hypersensitivity to the study medications.
* Diabetes mellitus.
* Peripheral vascular disease.
* Emergency surgeries.
Hearing Changes After Surgery

The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries

High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. As part of the study patient will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
* participants have normal or near-normal hearing thresholds in the un-operated ear

Exclusion Criteria:

* participants have hearing loss (PTA \> 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
* participants have medical conditions after the surgery which prevents having hearing tests
* participants have abnormal tympanometric results
Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

The regimen consisted of 3-day outpatient intravenous infusions of 1.8 mg/kg Bv on Day 1 of each 3-week cycle (as established by Younes and colleagues) sequentially combined with bendamustine (at least 24 hours after Bv, precisely on days 2 and 3 of the treatment cycle; as reported by Picardi et al) at a fixed dose of 120 mg/m2 per day.

All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell (PBSC) collection (performed with granulocyte colony-stimulating factor \[G-CSF\] and endoxan or plerixafor, if necessary) and proceeded to ASCT at any time beyond cycle 4.

The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment.

Prior to the first cycle of Bv-Bs, all patients underwent a clinical evaluation that included assessment of B symptoms, World Health Organization performance status, and measurement of palpable lesions. In particular, imaging procedures were conducted after the second and fourth cycles or prior to ASCT. The response was based on international criteria (Cheson et al, 2016). PET scans were considered positive or negative based on the Deauville 5-point scale criteria.

Eligibility Criteria:
Inclusion Criteria:

* patients age between 18 years and 60 years;
* histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment \[after 2 cycles of ABVD\] with interim FDG-PET/CT with Deauville scale score of 5 \[primary refractory patients\])
* treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively
* metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT)
* EGOG performance status 0-2 (or 3, if due to illness).

Exclusion Criteria:

* patients not fulfilling inclusion criteria
Neuromodulation for a Novel OCD Biomarker and Treatment

Although multiple treatments for OCD exist, slow symptom decrease, high remission, and significant side effects for some OCD patients limit their efficacy. More research into the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision making and other crucial functions that is affected by OCD). This proposal is based on highly encouraging preliminary data in both subsyndromal and treatment-resistant populations that shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings, the study will test whether repetitive modulation of relevant rhythm activity in the OFC can lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction. This research aims to increase knowledge of OCD and development of effective treatment with minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

(1) a primary DSM-5 diagnosis of OCD, (2) a score of 16 or greater on the YBOCS (3) at least 18 years of age; and (4) willingness and ability to provide informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

(1) a lifetime history of bipolar or psychotic disorders; (2) history of Tourette syndrome; (3) psychosurgery; (4) substance abuse or dependence (other than nicotine) in the past 3 months; (5) organic brain syndrome, mental retardation or other potentially interfering cognitive dysfunction; (6) severe depression (MADRS score of 30 or greater); (7) suicidal risk as determined by moderate or greater score on the Columbia Suicide Severity Rating Scale (C-SSRS); (8) pregnancy or lactation; (9) changes to pharmacotherapy for OCD or the initiation of cognitive-behavior therapy within the last 3 months; and (10) specific to the tACS and EEG procedures no metal implants in head, any implanted electronic devices, any skin sensitivity, color blindness or impaired vision despite correction, claustrophobia, and any history of epilepsy or neurological disorder.
Mobile Support to Improve Recovery and Treatment Court Outcomes

This study will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC. Upon completion of programming and testing of messages the investigators will enroll 40 participants and randomize participant to a control condition (TAU Group) or the intervention condition (TXS Group). Assessments will occur at enrollment, and day 30 follow up.

This study builds on pilot work in which Live Inspired LLC and research partners, have a history of collaboration in the development, revision, and evaluation of web-based and mobile phone technologies to promote behavior change. For this project the investigators will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC who are entering the program, at which time participants are expected to begin addressing underlying issues related to their addiction, and during which time participants are highly vulnerable to relapse and noncompliance with mandated activities. Outcomes will include participation in and compliance with Court-mandated appointments, abstinence from drug use (measured by urine testing), participation in substance abuse treatment, participation in education/employment training programs, and participation in related programs and workshops as directed by the Court. Data will be collected directly from Court records using a database established by the participating courts for this study.

Eligibility Criteria:
Inclusion Criteria:

To be eligible, participants must be

1. Age \>18;
2. Newly enrolled in the drug court program \[within 1 month\];
3. Own a mobile phone and use text messaging;
4. have a phone plan that allows unlimited texting;
5. Agree to participate in the study protocol and be available for all assessments through the final 30-day assessment; and
6. Speak and read English.

Exclusion criteria:

We will exclude anyone who is not able to participate in the intervention or assessments (e.g., deaf, blind, or otherwise impaired and unable to participate in computerized assessment).